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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 Problem Insufficient Information
Event Date 07/16/2016
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 diabetic ketoacidosis. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod¿s user guide warns to "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," and "if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death. " it advises ¿the easiest and most reliable way to avoid dka is by checking your blood glucose at least 4¿6 times a day. Routine checks allow you to identify and treat high blood glucose before dka develops. ".

 
Event Description

The patient's mother reported that her daughter was admitted to the emergency room after her blood glucose (bg) levels reached 898 mg/dl. She was diagnosed with diabetic ketoacidosis and treated with an insulin drip. The pod was worn between 4 and 24 hours.

 
Manufacturer Narrative

The returned product was evaluated and performed as designed. No defect or deficiency that would result in the cannula failing to insert correctly or the pump failing to deliver insulin 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
9786007000
MDR Report Key5878187
Report Number3004464228-2016-02378
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 07/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/15/2017
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL42405
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/04/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2016
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: 08/16/2016 Patient Sequence Number: 1
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