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...

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.

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