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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 14000
Device Problems Tube; Kinked
Event Date 07/25/2015
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to confirm the kinked cannula or to determine if it could have contributed to the reported hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod user guide warns, "test results greater than 250 mg/dl mean high blood glucose (hyperglycemia). If you get results above 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 250 mg/dl, follow the treatment advice of your healthcare provider. ".

 
Event Description

Customer's dad reported a kinked cannula and high blood glucose values in the high 200s and low 300s (mg/dl).

 
Manufacturer Narrative

The returned product was evaluated and performed as designed. No kink was observed in the cannula. No malfunction or other product condition that would have contributed to reported hyperglycemia was found.

 
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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 MA 01821
Manufacturer (Section G)
INSULET CORPORATION
600 technology park drive suit
billerica MA 01821
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5025458
Report Number3004464228-2015-00621
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41711
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2015
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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