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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD

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INSULET CORPORATION OMNIPOD Back to Search Results
Lot Number L41897, L41898
Event Date 11/04/2015
Event Type  Injury  
Event Description

My son has been using the omniopod system for about four weeks. During those four weeks he has experienced numerous episodes of hyperglycemia after insertion of new pods. He had to go to the emergency room and to his doctor using this period due to hyperglycemia and medical illnesses caused by his hyperglycemia.

 
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Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key5210435
Report NumberMW5057739
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Report Date 11/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device LOT NumberL41897, L41898
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: 11/04/2015 Patient Sequence Number: 1
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