BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7244477 · Received February 6, 2018

    Report

    Report Number
    3013756811-2018-03112
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 6, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY GAUGE DROPPED FROM 60% TO 20% AFTER BEING CONNECTED TO A POWER SOURCE AND THE CUSTOMER RECEIVED A POWER SOURCE ALERT. REPORTEDLY, AFTER LEAVING THE PUMP TO CHARGE, THE BATTERY CHARGED TO 100%. THE BATTERY GAUGE LATER DROPPED TO 40% THEN JUMPED BACK UP TO 100% WHILE DISCONNECTED FROM A POWER SOURCE. THE CUSTOMER'S BLOOD GLUCOSE WAS 230 - 457 (MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88168 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR