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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 01/01/2016
Event Type  Injury  
Event Description

The freestyle omnipod's failed to deliver insulin. They report that it is from pod failure, but i believe it is much more than that. I have tried contacting the manufacturer for a refund, and additional people who are supposed to call me back have failed to do so. My alc has increased, and my kidneys are showing damage from inefficient delivery of insulin. This began to happen at the end of last year, but i was guaranteed that other pods delivered insulin fine. I am proof that they don't. I have spent many precious hours trying to get the company to resolve this and my problem, but they refuse to move forward and do the right thing. I cannot afford to purchase another device until i receive a refund. I have had blood sugars 400 and even above, this is affecting my life in a very negative manner, and the device needs to be taken off the market until a solution is figured out. People like me have suffered from high blood sugars which come with terrible side effects. The device and the company need to be investigated and closed until the units no longer damage individuals health.

 
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Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET
MDR Report Key5587804
Report NumberMW5061794
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 04/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberUST400-FAOB
Device LOT Number130129583
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/16/2016 Patient Sequence Number: 1
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