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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 Problems Failure To Adhere Or Bond; Adhesive
Event Date 07/22/2015
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 hyperglycemia. Generally adhesion issues are due to variations in skin condition and are not considered malfunctions. No lot release records were reviewed, as the product lot number was not provided. 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

The customer reported that his blood glucose reached 900 mg/dl and was hospitalized as a result. They treated him with a manual injection of 9. 0 units of rapid-acting insulin.

 
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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 suit
billerica MA 01821
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5018846
Report Number3004464228-2015-00585
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2015
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2015
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

Patient TREATMENT DATA
Date Received: 08/20/2015 Patient Sequence Number: 1
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