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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP

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INSULET CORPORATION OMNIPOD INSULIN PUMP Back to Search Results
Model Number 14810
Device Problems Tube; Kinked
Event Date 07/14/2015
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported kinked cannula or to determine whether it contributed to the reported hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria.

 
Event Description

The customer reported her blood glucose reached 20. 0 mmol/l (360 mg/dl) and the cannula was kinked. The pod was worn between 24 and 36 hours.

 
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Brand NameOMNIPOD INSULIN PUMP
Manufacturer (Section D)
INSULET CORPORATION
billerica MA
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5021547
Report Number3004464228-2015-00499
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR,FOREIGN
Reporter Occupation
Report Date 07/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/01/2015
Device MODEL Number14810
Device Catalogue NumberZXY425
Device LOT NumberL41130
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2015
Was Device Evaluated By Manufacturer?
Date Device Manufactured05/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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