BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7739350 · Received August 1, 2018

    Report

    Report Number
    3013756811-2018-25952
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 1, 2018
    Report Date
    August 1, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004781509068
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 PUMP BATTERY INTERMITTENTLY STOPPED CHARGING WHILE PLUGGED INTO A POWER SOURCE DESPITE USING MULTIPLE USB CABLES, AND THE CUSTOMER NEEDED TO HOLD THE USB CABLE IN PLACE WHILE INSERTED INTO THE PUMP USB PORT IN ORDER FOR THE PUMP TO CHARGE SUCCESSFULLY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 171-378 MG/DL. THE CUSTOMER INDICATED THAT EITHER THE PUMP OR MANUAL INJECTIONS WOULD BE USED FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581496 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 00852162004781509068

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR