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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 04/11/2016
Event Type  Death  
Manufacturer Narrative

The returned product was evaluated and performed as designed. No defect or deficiency that would result in the reported diabetic ketoacidosis (dka). 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

A medical examiner called to report the death of a patient wearing the omnipod. The cause of death was identified as diabetic ketoacidosis (dka) with a secondary cause being hypertensive heart disease. The medical examiner requested the pod be evaluated to rule out a malfunction of the device. It was noted that the patient was last known to be alive on (b)(6) 2016 and found deceased on (b)(6) 2016 by the local police department. The personal diabetes manager (pdm) needed for use with the pod was not found with the patient or at the patient's home.

 
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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 Key5698742
Report Number3004464228-2016-01544
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date07/11/2017
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL42225
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/20/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/16/2016
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: 06/03/2016 Patient Sequence Number: 1
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