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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORP OMNIPOD

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INSULET CORP OMNIPOD Back to Search Results
Lot Number L40847
Event Type  Malfunction  
Event Description

The insulin delivery was noticeably different than another fda approved insulin delivery system. We have seen what we believe are two problems with the omnipod system on a somewhat regular basis. When we first attach and start a new pump, our daughter will go through a period of 4-8 hours where her blood sugar is high. Later, near the end of the 2-3 day life of a pump, we will see the same behavior again. She will have consistently high blood sugar levels that just do not seem to respond to insulin in the same way that they did in the midlife (12-48 hours) of the pump. We have performed an unofficial experiment that backs up our claim with some data. We used our previous insulin delivery system, a novolog insulin pen, to deliver 5 units into a cap that covers the needle that works with that pen. We then took an omnipod pod which we felt was not working near the end of its life (48-72 hours), which we had detached from our daughter without deactivating, and had it deliver 5 units into an identical cap. We put the two caps side by side and compared the levels. We did this test on two different occasions and each time the omnipod system delivered noticeably less insulin. This is consistent with our belief that the omnipod system delivers inconsistent amounts of insulin over its approved 72 hours of use. We have included copies of the pictures we have taken. Frequent high and subsequent low blood sugar levels.

 
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Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET CORP
MDR Report Key3818024
Report NumberMW5036120
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 04/28/2014
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/13/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device LOT NumberL40847

Patient TREATMENT DATA
Date Received: 05/13/2014 Patient Sequence Number: 1
Treatment
INSULIN (NOVOLOG U100)
OMNIPOD INSULIN DELIVERY
DEXCOM PLATINUM G4 CONTINUOUS GLUCOSE MONITOR
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