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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULATE CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN

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INSULATE CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14000
Device Problem Positioning Failure
Event Date 12/17/2015
Event Type  Death  
Event Description

The customer reported that her son was hospitalized and diagnosed with dka. Patient was drinking heavily and treated with insulin and the patient passed away.

 
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 and death. No lot release records were reviewed, as the product lot number was not provided. 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. ".

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULATE 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 Key5381402
Report Number3004464228-2016-00285
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number14000
Device Catalogue NumberZXP425
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2015
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

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