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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 Low Test Results
Event Date 05/28/2015
Event Type  Injury  
Event Description

The patient's mother reported that her daughter was having an attack, she was trying to hurt herself, she's going out of control and this is how she acts when her bg is high. She called 911 and upon the paramedics arrival and bg meter comparisons were performed. Her pdm read 160 mg/dl vs bg in the 500's mg/dl for the paramedic's meter. They gave her a manual injection of insulin (exact dosage was not provided) and stayed with her for an hour until she was stable. She confirmed that she was using the (uncleared) freestyle lite strips.

 
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported inaccurate low measurement or to determine if it could have contributed to the patient's paramedics visit. The patient was informed that freestyle lite test strips which are not cleared for use with the omnipod insulin management system integrated (freestyle) blood glucose meter. Qualification records were reviewed and the product lot met all acceptance criteria.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
billerica MA
Manufacturer Contact
david simard
600 technology park dr.
suite 200
billerica , MA 01821
9786007000
MDR Report Key4874987
Report Number3004464228-2015-00174
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 05/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number14500-5A
Device Catalogue NumberZXP425
Device LOT NumberL60213
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/25/2015 Patient Sequence Number: 1
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