epipen malfunction

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My sister needed an epi this weekend, and it failed to inject! Fortunately, I always carry three with me. (I was giving her my epis because she only had a twinject which she didn't know how to use.)

She tried about 3-4 times . . . I feel badly because I figured it was *her* so kept on telling her to push harder. (She didn't know how to use the epi--I gave her instructions. She was hesitant about the whole thing.) She bruises easily, and she got this *huge* bruise on her thigh.

I brought the epi back to the pharmacy. They are going to see if I can get my money back.

I'm surprised . . shocked, actually, that the epi didn't work. I wonder how common that is. In any case, my point is that it is a good idea to carry extras. I do feel I need three---one time in hospital, I required more than one dose. Plus it is good to have a third in case of accidents like this one.

On Feb 26, 2007

uh oh......

I do not even want to THINK about this.

My son carries two epi pens. Hopefully ONE of them will work.

Any expired pen we have we practice on an orange and there has never been a malfunction. 17 years of epi pens not one malfunction....

I would be sure the epi pen people follow up on this and tell you WHY this happened.

Refund is nice but a life?

Peg

On Feb 26, 2007

I keep anywhere between 2 and 4 with me for this exact reason.

On Feb 26, 2007

oh wow. I hope your sister is ok now.

Scary the epipen not working. We also carry at least 2 at all times but my reason has always been in case the first wears off before help arrives. Hmmm- wonder what caused the malfunction??

On Feb 26, 2007

You need to report this. I don`t know if any of you remember the recall around 1998 or 1999 (Peg-do you remember?) of certain lot numbers of Epipens because there was concern that certain lots would malfunction. Some of ours were in the lot number(s) that got recalled. We had epi jrs at the time, so the recall may have been just Epi juniors, don`t recall. So maybe there is something wrong that they need to do a recall.

On Feb 26, 2007

Scary stuff ... we carry two as well but more for the reason that KRC gave versus having a backup in case one doesn't work. With respect to the current malfunction, please post the results of whatever you find out to this thread. NP.

------------------ [url="http://www.NoPeanutsPlease.com"]www.NoPeanutsPlease.com[/url]

On Feb 26, 2007

I just figured that the pharmacy would look after it . . .and that the drug company would do the necessary testing and issue a recall if warranted. I'm not all that enthusiastic about pharmaceutical companies, but I do trust them to be vigilant on these sorts of issues.

But after posting today, I thought that maybe I should contact Health Canada. I first called the department that deals with adverse drug reactions . . .they said I should call the "health products and food branch inspectorate." I'm waiting for them to call me back.

I'm not sure whether I should send the epi to health canada (if health canada wants it) or to the drug company. I guess I'll wait until I call the company and until I hear back from Health Canada and then figure it out.

I'll be posting updates!

On Feb 26, 2007

Peg, I didn't mean to imply that I was only concerned about getting my money back.

krc, my sister is okay now, thanks for asking. The reaction didn't progress past the throat itchiness/ mild throat swelling stage. And her breathing wasn't compromised.

But we weren't too pleased with the service at the ER. she had to wait 45 minutes before she was admitted. And she still had a feeling of throat swelling/itchiness after taking the epi. (What's even worse is the nurse had written down "breathing difficulties" on her chart . . . she didn't have breathing difficulties, but if she had, they should have seen her immediately.)

She reacted to goat cheese (feta)---which makes sense to me because she is allergic to cow's milk. An attendant at the hospital though said that goat cheese is commonly cross contaminated with nuts or contains almond flavouring. I kind of doubt this cheese was----there were very few ingredients. But she is looking into it.

On Feb 26, 2007

Oh Lisa I knew that. I'm not the sort to jump on you. I would really like though to hear what the manufacturers say. Peg

On Feb 26, 2007

I am so glad your sister is OK. You were *meant* to be with her at that moment she was having a problem, so your epipen would be there.

Reading this whole thread has convinced me that I should carry epipens from two different batch numbers (I always carry two in case one malfunctions or a second one is needed).

On Feb 26, 2007

I remember several years ago--I'm thinking back around 2001 even--someone posted that they were on vacation in a rural area--at a B&B I think--and their first epi malfunctioned. They had called an ambulance, and I can't remember if the ambulance brought epinepherine, but the family had to use the second epi as the first. After reading that, we've always carried at least two with us.

On Feb 26, 2007

Thanks, Peg. Was just being overly sensitive at this end [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

And thanks Mookie---yes, I guess I'm lucky that I was around at the time. Lately, she's been trying foods she has reacted to, but she tries to save the experiment for when she is home as opposed to when she is alone in her apartment. This past week was Reading Week in Ontario universities so she was home.

Although it wasn't exactly a good experience, a number of good things came out of it. For one thing, my sister will know how to use an epipen. She wasn't sure how big the needle would be and hesitated to take it. . .but wouldn't let me do it. I hope there's not a next time, but if there is, she won't be so concerned.

Also, she is taking the milk allergy more seriously, and I don't think she is going to be testing any more foods like this for awhile. (She tried milk a few weeks before the goat cheese--same reaction, but not as severe.) She is going back to an allergist for testing when she gets the time---I suggested she go to my allergist, but she wants to resolve things with her previous allergist who isn't in her good books at the moment---He didn't take her milk allergy seriously because she had a negative SPT. She thought she could *never* have a severe reaction to goat's milk or to milk . . .after all, her SPT test was negative. (People in my family don't always listen to me about allergy issues.)

I also realized that I am not comfortable administering the epi to another person and perhaps should practise with the epipen trainer on someone else.

It is odd, because I'm totally fine with giving myself an epipen.

Good point about the different batch numbers!

On Feb 26, 2007

'Sorry you and your sister had to go through all that. Do you happen to know the lot no# on the epipen? If I had any with the same lot #, I'd sure want my second epipen to be a different lot # in case of any trouble with this particular batch. At least until we know more. Thanks.

On Feb 27, 2007

I'm a bit hesitant to post the lot # now until they figure out what is wrong with the epi . . . maybe i'm being paranoid, but I wouldn't want to spread unsubstantiated info. around and then to get sued or something by the company. I will post the lot # when I get more info. on the problem.

The man whom I called at Health Canada hasn't called me back.

But I'm definitely going to try to get Health Canada to investigate as opposed to trusting King Pharma Canada (which has the exclusive rights to market epipens in Canada--they are the ones to contact.)

[This message has been edited by LisaM (edited March 01, 2007).]

On Feb 27, 2007

Lisa, I would report it to whatever organization in Canada is the equivalent to the FDA in the U.S. Is that Health Canada?

[This message has been edited by Carefulmom (edited February 27, 2007).]

On Feb 27, 2007

Yes, I believe Health Canada has the same role as the FDA. But it isn't clear which department I should call.

I was passed on to the "health products and food branch inspectorate." I called on Monday afternoon and left a voice message, but I haven't heard back yet.

[This message has been edited by LisaM (edited February 27, 2007).]

On Feb 28, 2007

When I called CFIA (Canadian Food & Inspection Agency) regarding canned food that was bad they called me back that morning, and came to my home that afternoon to pick up the product.

[url="http://www.hc-sc.gc.ca/cps-spc/index_e.html"]http://www.hc-sc.gc.ca/cps-spc/index_e.html[/url]

Click on "Consumer Product" under the heading "Want to report an incident?"

I followed through some links, and it appears this area puts out safety reports/recall info on some medications (I don't know if there are different areas that would as well).

The link provides snail mail, e-mail, and telephone number.

On Feb 28, 2007

This is scary, esp for kids in school expected to self-inject. Would a child even know if it didn't work?

On Mar 1, 2007

Thanks for the link, Annamarie. I thought I'd give the "Health products and food branch inspectorate" one more try. This time when I left a message, the person whom I was referred to answered me back within 5 minutes. (I think I got a different person.)

Anyway, I'm going to mail a letter explaining what happened along with the epipen, packaging (if I can find it) and instructions, etc. to the "Medical Devices Unit, Health Canada."

They asked me to send a second epi from the same batch (I do have one) . . . but since I wouldn't be reimbursed for either epi, I'm going to hang on to the one.

I did mention to Health Canada that King Pharma said they don't issue recalls---the gov't agent thought that that might have been because they are the distributor and marketer and not the manufacturer so, no, they wouldn't be issuing recalls. Maybe, then, there was some miscommunication. In any case, it is best to let Health Canada take care of it rather than to trust the company.

I also called King Pharma back to explain that I was going to send the epi to Health Canada . . . I explained why I was sending it to them, too. The person I spoke to seemed more concerned about the issue this time---she wanted to make sure that she had all the accurate info. down, and she had done the research to check to see whether they had gotten complaints about this particular batch---they haven't.

(I complained about a previous conversation I had with a representative from King Pharma, but I edited the post to tone down the criticism.)

On Mar 1, 2007

It isn't that the medicine wasn't delivered properly----it was not delivered at all. There is no exposed needle. As long as the child knows that the needle is supposed to come out of the end, he/she would know that it didn't work.

On Mar 1, 2007

I`m sure my dd would notice. She has injected an epi into an orange many times.

On Mar 1, 2007

Quote:

Originally posted by Carefulmom: [b]You need to report this. I don`t know if any of you remember the recall around 1998 or 1999 (Peg-do you remember?) of certain lot numbers of Epipens because there was concern that certain lots would malfunction. ...[/b]

I remember reading about this and also someone suggested at that time to get Epis from different lot #s in case there is a problem with a certain lot#.

And I agree about reporting it. I'd contact Dey immediately to get them involved also.

Keep us posted with their replies please.

On Mar 2, 2007

LisaM, thank you for taking the time to do all of this. It helps to keep all of us and our children safer. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

On Mar 22, 2007

Thanks, AnnaMarie [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

No definite news re: the epipen investigation, but just to let everyone know, the investigation is ongoing.

I was actually quite impressed with how quickly health canada acted---they sent me a letter and an email right after they received the product. They don't have the expertise to do the product testing, though, so they're sending the epi back to King Pharma, Canada . . .King Pharma, in turn, will send it to the manufacturer.

Called King Pharma today to ask for a refund. They tell me I need to wait until they get the manufacturer's report back. I pointed out that they had received the product and could tell that it hadn't worked properly as the cap was off and the needle wasn't exposed.

We're talking about a life-saving medication here. It is far easier to get a replacement for practically anything else!

On Apr 29, 2007

I did hear back from Health Canada---way back in early April (sorry for the delay in getting back to everyone).

The results of the investigation: the epipen was *not* defective. The needle was not exposed when sent to Health Canada, and was not exposed when sent to King Pharma, but King Pharma sent it to the manufacturer. And the manufacturer said it autoinjected with a normal amount of pressure.

Health Canada reviewed complaints since 2003--there have been no complaints about this particular lot.

So I guess this case is closed. I'd suggest that anyone faced with a similar situation test the epipen on a grapefruit or something in the presence of a pharmacist or doctor (if in fact they are willing to sign on as witnesses.)

On Apr 29, 2007

I'm glad your sister is o.k. I had an epipen malfunction last week as well, but luckily it was not in an emergency. It had expired in Jan 2007 and instead of throwing it out, I jabbed it into an apple and reminded my family how to do it. As it jabbed we heard something literally hit the ceiling. The piece on the back of the Epipen came apart and broke off. The needle went into the apple, but I wanted to report it to the Pharmacy. I've tried 2x now, and the owner has not been there either time. I will call EPIPEN directly tomorrow. Has anyone else had this experience????

On Apr 30, 2007

Quote:

Originally posted by JenEmm: [b]I'm glad your sister is o.k. I had an epipen malfunction last week as well, but luckily it was not in an emergency. It had expired in Jan 2007 and instead of throwing it out, I jabbed it into an apple and reminded my family how to do it. As it jabbed we heard something literally hit the ceiling. The piece on the back of the Epipen came apart and broke off. The needle went into the apple, but I wanted to report it to the Pharmacy. I've tried 2x now, and the owner has not been there either time. I will call EPIPEN directly tomorrow. Has anyone else had this experience????[/b]

Since it was expired when you used it, I doubt they'll spend the time and resources investigating it. Realistically, there's no way that should have happened, even if three months expired. Scary!

On Apr 30, 2007

Quote:

The piece on the back of the Epipen came apart and broke off.

Are you talking about the grey cap on the end that you are supposed to remove? I'm just trying to figure out what broke off.

On Apr 30, 2007

I am also wondering...did you take off the grey end cap? I looked at my epi pens and it doesn't look possible that anything could shoot out the top except the cap, which should be removed before injecting. Let us know!

On Apr 30, 2007

Of course I took the grey cap off!!!!!! but I would have asked the same thing [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

I'm looking at it now if you look at the top of the epi (after taking off the grey cap) there is a hole. If you look closely under a light- that piece where the hole is is fused to the rest of the epi, and it was that piece that flew off. I'm looking at another one at the same time (whose grey cap is off and I injected it into an apple as well)and it really appears to be one piece. It took 3 people about 5 minutues to find the piece in the kitchen!

On Apr 30, 2007

I called today, no answer. Left a message. I will keep you posted on what they say. BTW-I called the canadian number

On Apr 30, 2007

I've always thought it was just one piece. I don't have any old ones -- we had a very sick orange that we all poked with expired epi's recently. [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img] Next time, I'm going to try to remember to look to see if I can see where it joins. Might just take the whole thing apart just for the heck of it.

How long ago did the epi-pen expire? Some plastics will wear down over time -- but that should be long past the expirey date. One of the ones we recently used expired about three years ago -- the liquid actually was yellowed, but the pen worked fine.

On May 1, 2007

It expired in Jan 2007.

On May 1, 2007

I just got off the phone with a rep from EPIPEN Canada. I will send the unit along with the broken piece , and it will be sent to the manufacturer is the US for analysis.

On May 1, 2007

Glad to hear they at least want to examine it. If you hear back from them, please post. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

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