Minimed Pump Field Correction
EDITED: The FDA's Enforcement Report for the week of July 11th has announced a Field Correction for some of the Minimed Paradigm Insulin Infusion Pumps. The report is as follows:
PRODUCT:
Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007
CODE:
All serial numbers for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
RECALLING FIRM/MANUFACTURER:
Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.
REASON:
Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE:
334,000 pumps
DISTRIBUTION:
Nationwide and Internationally
For questions, you can call 1-800-MINIMED or visit the Minimed website at www.minimed.com.
Comments
- At 04:11 PM on Thu, Aug 23, 2007 mary wrote:
Emily I was very interested in your post.My granddaughter recently passed away and she had the minimed pump. I would appreciate it if you could email me at nnmrcstl@yahoo.com I have a few questions on the operation of the pump.
- At 03:43 PM on Fri, Jul 20, 2007 Emily wrote:
I was wearing a minimed pump while driving cross country, and I had gotten one of those adapters that you can plug a cell phone carger into. (A regular cell phone carger for a regular outlet- not a car cell phone carger.) Anyways, I plugged a stereo into it because my radio wasn't working in my car. I felt high, so I checked my blood sugar. It was 300, so my pump wanted to give me some insulin. I tried to lower the dose of insulin, so I pushed the down arrow. When I stopped pressing the down arrow, however, the insulin dose kept going down as though I were still pressing it. I figured it was just a computer error or something, so I pressed the up arrow and held it, trying to get it figured out.. and then it started going up, but even after I stopped pressing the up arrow, the dose kept raising. So then I started thinking that it was really weird, and I was wondering whether it was actually giving me insulin, even though I had ever pushed the final button. I disconnected and saw that it was giving me insulin. When I pulled over, I freaked out and realized that it had given me 9 units of insulin without me even asking it to. Then my mom looked at it.. told me to eat some crackers and that it'd be fine after that.. so we took off driving again. About five minutes later, I felt my pump vibrate in my pocket, and i pulled it out and it gave me another four units.
Everyone thinks that it happened because the adapter I was using was made for a big semi truck, not a tiny toyata tercel, plus I had tons of other things plugged into the adapter. Minimed wouldn't explain anything.. they just told me to send it in and they'd send me another one- but that's a huge deal! This happened about a year and a half ago, and they are just sending out information on MRI's and things now?
I heard that this happened to someone who was pregnant, while she was sleeping, and she got such a high over-dose of insulin that she went into a coma and her baby died. I just heard that there were lawsuits against minimed because of it.
I recently changed pumps. I'm on the Omnipod now, and I like it a lot more. It's a two peice thing. The pod part is on your skin and has the insulin in it, and the PDM is a remote control/meter which measures your blood sugar, allows you to enter your carbs, and tells the pod how much insulin to give. But if it comes in contact with an electric magnetic field, or if it short circuits in anyway, it will just shut off.
I hope Minimed gets everything sorted out.
- At 04:03 PM on Sat, Jul 14, 2007 Steve Ducote wrote:
I received a new 722 pump S/N 205701 on June 19th, 2007. Does this recall affect my new pump?
Recall # Z-1007-2007
- At 11:51 AM on Fri, Jul 13, 2007 Hisham Megahed wrote:
Dear Sir/ Madam,
I wear a minimed paradigm 722 pump and have undertaken an MRI while wearing it. The alarm did not go on during the procedure, however I do get more episodes of hypoglycemia than usual since this insidence.
How do I know if there was somthing wrong with my pump? Thank you.
Yours Sincerely,
Hisham Megahed - At 06:31 PM on Thu, Jul 12, 2007 Vivian wrote:
Please make sure everyone understands that this recall is only on units that users have worn while going through an MRI. Thanks.
I have a MMT722 Insulin Pump with a S/N PAR384567H. Is this one with a recall? Please advise.