BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5899743 · Received August 24, 2016

    Report

    Report Number
    3007981285-2016-97386
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    July 8, 2016
    Report Date
    August 5, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP IS NOT GIVING A VIBRATION SENSATION. THE CUSTOMERS BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED RANGE (250-350 MG/DL) THE CUSTOMER TOOK A BOLUS TO STABILIZE BG LEVELS. REPORTEDLY, WHEN THE PUMP GOES OFF THE CUSTOMER CAN HEAR THE VIBRATION MOTOR MOVING BUT GETS NO ACTUAL VIBRATION SENSATION. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT WAS PERFORMED. IT WAS INDICATED THAT THE CUSTOMER WOULD CONTINUE TO USE THE PUMP UNTIL THE REPLACEMENT ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553567 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other