BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 11088295 · Received December 29, 2020

    Report

    Report Number
    3013756811-2020-149992
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 15, 2020
    Report Date
    December 29, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004781
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE POWER SOURCE ALERTS AFTER PLUGGING THE PUMP INTO A WALL OUTLET. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS BETWEEN 172-200 MG/DL. REPORTEDLY, THE ALERTS CLEARED AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552705 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR