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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 05/27/2016
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm any product malfunction or other product condition to have contributed to the patient's ketoacidosis and hospitalization. No product lot number was reported therefore no lot release records were reviewed. The omnipod¿s 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 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 also 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 father reported that his son was vomiting and that he was nearing a coma situation by the time he arrived at the emergency room. He was admitted into the intensive care unit with diabetic ketoacidosis. He stayed in the hospital for 24 hours before being released. He did not provide any further information regarding the hospitalization or his son¿s treatment.

 
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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 Key5753587
Report Number3004464228-2016-01782
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2016
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2016
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: 06/27/2016 Patient Sequence Number: 1
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