BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 7200786 · Received January 17, 2018

    Report

    Report Number
    3013756811-2018-01233
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    September 18, 2017
    Report Date
    January 17, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 BATTERY WAS OBSERVED TO BE DEPLETING MORE QUICKLY. REPORTEDLY, THE BATTERY DEPLETED 50% WITHIN ONE DAY. THE PUMP SHUT OFF DUE TO INSUFFICIENT POWER MULTIPLE TIMES DUE TO THE DEPLETION ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 210-290 (MG/DL). REPORTEDLY THE CUSTOMER WOULD CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44478 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR