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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; Bent
Event Date 07/28/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia. 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. ".

 
Event Description

Customer's dad reported his son had increased blood glucose levels which reached 330 mg/dl and he did not think the pod was delivering insulin accurately. When the pod was removed he said the cannula looked bent. The pod was worn between 4 and 24 hours. Insulin history is as follows: (b)(6).

 
Manufacturer Narrative

The device was found to function as intended with no evidence of any damage or manufacturing deficiencies that would have either directly caused or contributed to a deficiency in delivery. A bent cannula was observed, but it is considered to have occurred post use. Had it occurred during use, there would have been pressure build up in the fluid path resulting in a rapid increase in pulse widths and/or an occlusion alarm being generated. No malfunction or other product condition that would have contributed to the 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
suite 200
billerica MA 01821
Manufacturer Contact
derek sammarco
600 technology park drive
suite 200
billerica , MA 01821
MDR Report Key5950680
Report Number3004464228-2016-02832
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 08/20/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/12/2017
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL42037
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/12/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/13/2015
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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