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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 01/04/2015
Event Type  Injury  
Manufacturer Narrative

The returned device was evaluated and performed within specifications. The reported inaccurate low blood glucose reading error was not confirmed. Qualifications records were reviewed and the product lot met all acceptance criteria.

 
Event Description

The patient's mother reported while sitting in the back seat of the car her daughter's blood glucose result was 60 mg/dl and that she was having a seizure so she was rushed to the hospital in an ambulance. At the hospital a bg meter comparison was performed. Her pdm read 223 mg/dl vs 481 mg/dl for the hospital's meter. She stayed in the hospital for a week before being released. She did not provide any further information regarding the hospitalization or her treatment.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
billerica MA
Manufacturer Contact
michael doyle
600 technology park drive ste 200
billerica , MA 01821
9786007000
MDR Report Key4527412
Report Number3004464228-2015-00031
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2015
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 NumberL60107
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/23/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received01/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2013
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: 02/06/2015 Patient Sequence Number: 1
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