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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN

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INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14810
Device Problems Tube; Kinked
Event Date 07/21/2015
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. The mylife omnipod user guide warns "test results greater than 13. 9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia). If you get results below above 13. 9 mmol/l [250 mg/dl], but do not have symptoms of hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall above 13. 9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider. ¿.

 
Event Description

The customer reported his blood glucose reached 22. 1 mmol/l (398 mg/dl) and that the cannula was kinked. The pod was worn between 36 and 48 hours.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
600 technology park drive
suite 200
billerica
Manufacturer (Section G)
INSULET CORPORATION
600 technology park drive suit
billerica MA
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 
9786007000
MDR Report Key5017690
Report Number3004464228-2015-00568
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER,DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 07/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/01/2016
Device MODEL Number14810
Device Catalogue NumberZXY425
Device LOT NumberL41446
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/30/2014
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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