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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 14500-5A
Device Problem Device Operates Differently Than Expected
Event Date 03/31/2016
Event Type  Injury  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported hospitalization for renal failure. 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 mother reported recent changes in basal rate and her blood glucose level was not going down. Pdm appeared to be working incorrectly. Daughter was hospitalized with kidney failure and was having a shunt placed for dialysis.

 
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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
9786007000
MDR Report Key5614256
Report Number3004464228-2016-01266
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/31/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number14500-5A
Device Catalogue NumberZXP425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/28/2016 Patient Sequence Number: 1
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