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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 07/30/2015
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 and dka. 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

Customer was hospitalized with high blood glucose and dka. The customer was treated at the hospital with an iv drip. The customer's mother reported the following blood glucose and insulin history as follows: blood glucose values were reading "high" (> 500 mg/dl) a few hours prior to going to the hospital, 389 mg/dl at the time of departure to the hospital, 289 mg/dl when arriving to the hospital, and 303 mg/dl based on lab results at hospital.

 
Manufacturer Narrative

The returned device was evaluated and the investigation found evidence of an internal leak. Its root cause was determined to be a damaged cannula. Qualification records were reviewed, and the product met all acceptance criteria.

 
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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 Key5029546
Report Number3004464228-2015-00647
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2015
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? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/25/2015 Patient Sequence Number: 1
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