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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 05/27/2016
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported inaccurate high bg measurement or to determine if it could have contributed to the patient's hospitalization. No product lot number was reported therefore no lot release records were reviewed. 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 patient's father reported his daughter's blood glucose history is as follows: time: 5:05 am, bg (mg/dl): 95. He then noticed a pod alarm. 10 minutes later 11. She had a diabetic seizure while she was sleeping so he called for the paramedics. Upon their arrival her bg was reading at 11 mg/dl (with the emt's meter) and the pdm was reading at 95 and 94 mg/dl. They used something to help bring up her bg levels. Dad stated that he was not sure what the paramedics gave his daughter. She was taken to the hospital where they monitored her bg levels overnight.

 
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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
suite 200
billerica MA 01821
Manufacturer Contact
derek sammarco
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5749303
Report Number3004464228-2016-01768
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2016
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
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2016
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/24/2016 Patient Sequence Number: 1
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