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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 10/22/2015
Event Type  Injury  
Event Description

My (b)(6) daughter, diagnosed at (b)(6) with type 1 diabetes, has been using insulet omnipod for four years. Though some isolated equipment problems sporadically, the recent failures of this omnipod, resulted in high blood sugars and ketoacidosis. Stress beyond belief, trouble in school, missed school, loss of sleep and inflicted illness which further increase blood sugars. Additional pod changes which are extremely painful and many, many tears. Ketoacidosis was treated with additional insulin which were painful boluses as well. Poor kid suffered and was almost hospitalized due to these product failures. Now i am advocating to obtain replacements for these pods in this lot.

 
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Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET
MDR Report Key5235214
Report NumberMW5057925
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberOMNIPOD
Device LOT NumberL41904
Was Device Available For Evaluation? No Answer Provided
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: 11/14/2015 Patient Sequence Number: 1
Treatment
FLOVENT
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