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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 14500-5A
Device Problem High Test Results
Event Date 09/27/2015
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported inaccurate high measurement or to determine if it could have contributed to the patient's ketoacidosis and hospitalization. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod user guide warns "if you are experiencing symptoms that are not consistent with your blood glucose reading and you have followed all instructions described in this user guide, call your healthcare provider immediately,"and advises "you should perform a control solution test when you suspect that your meter or test strips are not working properly, when you think your test results are not accurate, or if your test results are not consistent with how you feel. ".

 
Event Description

The customer's mother reported that her daughter's blood glucose was reading at 238 mg/dl with an alternative meter and that the pdm meter was reading at 349 mg/dl. Patent went to hospital and diagnosed with diabetic ketoacidosis. At the hospital a bg comparison was done and that the pdm was reading 100 points higher than the hospital's meter.

 
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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
derek sammarco
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5180928
Report Number3004464228-2015-01392
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 09/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number14500-5A
Device Catalogue NumberZXP425
Device LOT NumberL60222
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/03/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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