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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; Activation, Positioning or Separation Problem
Event Date 11/23/2015
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to confirm the reported delayed cannula deployment or to determine its root cause. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod user guide warns "check the infusion site after insertion to ensure that the cannula was properly inserted. The pdm will automatically remind you to check your blood glucose 1. 5 hours after each pod change. If the cannula is not properly inserted, hyperglycemia may result. Verify there is no wetness or scent of insulin, which may indicate the cannula has dislodged," and "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

The patient's blood glucose level was over 500 mg/dl. The pod was not worn. The patient's mother stated that cannula deployed 5 minutes later after it had already been set to the side.

 
Manufacturer Narrative

The returned device was evaluated and performed as designed. The reported needle mechanism failure was not confirmed. The pod was received with cannula fired and needle fully retracted.

 
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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
derek sammarco
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5311383
Report Number3004464228-2015-02769
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/05/2017
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41905
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2015
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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