This week, J&J’s Animas is recalling a batch of 45,000 faulty insulin cartridges shipped between Nov. 30, 2010, and Jan. 4, 2011, that reportedly can leak insulin, resulting in the delivery of less insulin than intended. Note that the pump most likely will not alarm if there is an internal leak. If you are affected by this, you should be receiving an email and a letter from the company shortly, in addition to a set of replacement cartridges (free of charge) that will be FedEx’d to you tomorrow. Now that’s some pretty nice service…
Photo: Phil King
I spoke with Animas’ new Director of Global Communications Caroline Pavis today to get the details:
“We’ve been getting a few calls in the last few days, saying some pump units seemed to be leaking insulin — the inside was wet, and the customers could smell the insulin. Our quality team quickly investigated the issue, and discovered the problem was associated with the cartridges, specifically with the plunger of these cartridges. Of course, this could cause under-delivery of insulin… so we are advising patients to stop using them immediately. We’re instructing them to go to their backup insulin plan until they receive their package of replacement cartridges.”
Pavis says the company was quickly able to identify and isolate the problem to a shipment of six lots — five in the US and one in France. About 5,000 customers are affected in total, just 10% of their 50,000 customer base. I realize that 45,000 bad cartridges may sound like a lot to you and me, but Animas actually ships about 8 million cartridges per year, Pavis says. So in the scheme of things, the reach of this is pretty small.
Wondering if your doctor will know about this? Animas is also sending out letters to about 2,600 healthcare professionals, and planning to send emails to those reachable online (kind of hard to believe, but many still aren’t).
If you’re an Animas user, and you (or your doctor) don’t hear from the company soon, you can call the toll-free Animas Customer Support line at 855-254-5668 or the toll-free number on the back of your Animas pump at 1-877-937-7867, Pavis says.
When I pushed her on the details of what went wrong, she said the faulty cartridges were made by a partner company in Singapore. Animas has “immediately set up new quality procedures and protocols, including testing (every batch of cartridges) now in our J&J plant in West Chester, PA.” In the past, the company’s relied on on-site quality testing at international manufacturing sites.
“We’re seeing this as an opportunity to take another step,” Pavis tells me. “We don’t want to see any patients experiencing any health concerns… and we really, really want to be as transparent as possible on this.”
I have to give the company kudos for jumping on this right away. The official statement hasn’t even been issued yet, and a full reaction plan is already in place. Plus we’ve got the story here at the ‘Mine! I’m not an Animas user myself, but happy to see this kind of fast and comprehensive customer service becoming the norm.
[...] This post was mentioned on Twitter by DiabetesMine and Cherise/LADA, HJ Rodriguez. HJ Rodriguez said: RT @DiabetesMine: Just posted: NEWSFLASH – Animas to Recall Insulin Pump Cartridges http://cot.ag/ggfgNG #diabetes #dblogs [...]
The letter I received says:
What should I do if we have unused cartridges from the lots listed above? Set them aside for return to Animas. We will be sending instructions and materials to return these cartridges.
So – maybe don’t throw them out until you’re told the procedure.
And yup, I have five boxes of the recalled cartridges.
Thanks for the more indepth info! Someone had posted a brief discussion on Tudiabetes which made me question the validity of the claim – and as always – I’m always needing more valid proof then just a few words. I did contact Animas Canada as well yesterday – since I’d not seen anything reported at FDA website or Animas USA – so many thanks!!!
Colleen – weren’t you reporting that you were having some wacky BG’s? So maybe this has been the problem.
[...] could result in not delivering the full amount of insulin that was bolused. Read Six Until Me and Diabetes Mine for more [...]
I have 3 boxes of recalled cartridges. Just got off the phone w/ TERRIBLE customer (non)service @ the Animas Cartridge Replacement Center. They sent me 1 replacement box last week, told me to contact Edgepark Medical (my distributer) to get the other 2 boxes replaced. Edgepark just told me they are “not allowed” to do anything but give out the Animas recall phone #. Animas then told me they cannot help me either, have to ask Edgepark. When I asked to speak w/ a supervisor at Animas, the rep said “we have no supervisors on the floor right now, they’re all busy and no one is in charge.” SCARY. I’m more than a little peeved and unsure what to do next–maybe call the regular Animas customer service # and complain loudly. I’ve never had bad experience w/ either Animas or Edgepark before. Now they’re both pointing the finger at the other and saying “not me!” Completely frustrating, to say the least.
Update: Just got a call back from Animas, apologizing for and documenting my terrible (non)customer service experience w/ their Cartridge Replacement Center this AM. MUCH better response this time. The supervisor who called me back told me what to expect, then had me wait while she told the customer service rep what to tell me, then connected me with the customer service rep who very politely and helpfully placed my request. She also told me what to do if anything goes wrong and I don’t get the right # of replacement cartridges in the next 7 days. I feel much better after this follow-up.
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]
[...] was announced on J&J’s website last month and initially reported by diabetes-news website DiabetesMine with a lower estimate of recalled [...]