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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET OMNIPOD

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INSULET OMNIPOD Back to Search Results
Model Number UST400-FAOB
Event Date 03/13/2014
Event Type  Malfunction  
Event Description

Since we switched to the new omnipod system with smaller pods, we have had many issues. The most recent being recalled test strips in conjunction with the omnipod personal diabetes manager (pdm). The strips which were recalled still worked properly with the freestyle freedom meter, meaning the issue (blood glucose reading showing much lower than what was accurate) was the pdm and the strips being used together. A lower blood glucose reading results in more carbohydrates and less insulin or no insulin being given. A false low reading, for example the pdm reads 65 when the blood glucose is actually 165, would result in me giving my child 30 carbohydrates with no insulin. After which her blood glucose would be a very high number damaging her eyes, kidneys, veins, heart. I have received the replacement strips from abbott and still the issue continues. A false low reading actually results in actions being taken that produce a higher a1c. Proof of which is my child's a1c raising from 9. 4 to 10. 4 in a very short period of time. This is damaging to every part of her body. We have also had many pod failures. We have had the pod fail during a bolus. The pdm read pod failure no insulin delivered. The insulin on board (iob) was 0. We changed the pod and delivered the insulin again. After the delivery was complete, the iod showed. 05 less then double the amount of insulin which should be on board. Meaning if 1u was supposed to be on board, there was actually 1. 95u on board. This has happened more than once. Another pod failure was during insertion of the cannula. We were applying a new pod when the needle didn't insert. We deactivated the pod and started the process of removing it when the needle suddenly inserted leaving a bruised bloody spot about the size of a nickle. Other pod failures include errors during basal delivery and errors while simply setting down. I have spoken with our representative about these issues and he stated that i was priming the pod incorrectly. The representative said the pod needs to be touching the right side of the pdm to correctly prime. The users manual states the pod and pdm need to be touching but not on a specific side or area. I usually set the pod directly on top of the pdm while priming, which means they are touching on the right side. Since talking to the representative, i have moved the pod to right side of the pdm and still the issues continue. I have spoken with many others having the same problems we are. Some have even had multiple new pdm sent to them and still the issues remain. My daughter is (b)(6) old. She is not capable of expressing when her blood sugars are high or low. She does not understand having to eat an extra 45 carbohydrates (immediately after eating 45 for dinner) because her pdm has dosed her twice. Our insurance will only allow us to get an insulin pump every five years. We can not switch pumps at the moment. We have switched meters and are using the accu-check nano and manually entering blood glucose numbers into the pdm. This is very frustrating as it creates an opportunity for human error, requires more equipment being carried everywhere we go, and eliminates one of the reasons for us choosing the omnipod to begin with (built in meter). I do not believe the new system was ready for being put on the market. It has many issues that need to be addressed. Everyone of these issues is life-threatening and could result in death.

 
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Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET
MDR Report Key3695503
Report NumberMW5035108
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2014
5 DeviceS WERE Involved in the Event: 1   2   3   4   5  
1 Patient Was Involved in the Event
Date FDA Received03/19/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Device EXPIRATION Date03/16/2017
Device MODEL NumberUST400-FAOB
Device LOT NumberL60110

Patient TREATMENT DATA
Date Received: 03/19/2014 Patient Sequence Number: 1
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