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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 OMNIPOD
Event Date 06/05/2015
Event Type  Injury  
Event Description

Omnipod moved to a smaller insulin pod. Ever since omnipod moved to the smaller insulin pod extra insulin has been being released from the pod during flights. I was unaware this was happening. My doctor at the time was also unaware. However, i was expressing my concern to a colleague who then did some research online and discovered that the nih had tested medtronic and animas insulin pumps a few years ago and proved that extra insulin is being delivered during flights. I then went to my doctor and told her about it - which she was unaware. So i saw someone else in the practice who had confirmed she knew that animas and medtronic delivered extra insulin. I travel on average 8 flights a month so this has been a big problem for me. I tried many compensating behaviors to account for this such as running temporary basals, turning off the insulin pump, eating extra food before flights and under blousing, bringing numerous supplies to treat hypoglycemia. I have also reported this numerous times to omnipod. I have now resorted to literally removing the omnipod on flights. What i have observed when removing omnipod on flights is that insulin is bubbling out of the cannula during take-off. But not at any other time of the flight. I am very insulin sensitive - only requiring around 12-18 units total in one day - therefore the extra insulin - which the nih reported could be on average (b)(6) for animas and medtronic is equivalent to eating a big meal for me. I am very, very concerned about this issue and want other who are insulin sensitive to be aware. I am so afraid that a child or someone who is unaware of the issue will go on a flight and have a very serious hypoglycemic event.

 
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Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET
MDR Report Key4838212
Report NumberMW5043035
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberOMNIPOD
Event Location No Information

Patient TREATMENT DATA
Date Received: 06/05/2015 Patient Sequence Number: 1
Treatment
OTC MEDS: MULTI-VITAMIN, ZINC PROBIOTIC, CRILL OIL
RX MEDS: INSULIN OMNIPOD, DEXCOM, TIROSINT,
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