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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 Activation, Positioning or Separation Problem; Needle
Event Date 07/25/2015
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to confirm the reported needle mechanism failure to fire and deploy 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 customer reported that her blood glucose reached "high" (>500 mg/dl) and the pink slide was not showing after wearing the pod between 1 and 4 hours.

 
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
david simard
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5032240
Report Number3004464228-2015-00653
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41752
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/19/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/13/2015
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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