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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 Retraction Problem; Needle
Event Date 07/20/2015
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported needle mechanism issue (fail to retracted) or to determine if it could have contributed to the reported hyperglycemia, or to determine the root cause. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod¿s user guide warns to "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," 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 above 250 mg/dl, follow the treatment advice of your healthcare provider. ".

 
Event Description

The customer reported her blood glucose reached 404 mg/dl and that the needle did not retract back into the pod. She stated that the site was painful, swelling, and red and there was bleeding noted at the insertion site. The pod was worn between 36 and 48 hours.

 
Manufacturer Narrative

The returned product was evaluated and the failure of the needle mechanism was confirmed. Mechanism rails-wings did not capture slide insert/did not go through was determined to be the root cause.

 
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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
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 Key5015966
Report Number3004464228-2015-00564
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41666
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/09/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2015
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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