BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7263735 · Received February 12, 2018

    Report

    Report Number
    3013756811-2018-04588
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 21, 2018
    Report Date
    February 12, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS COMPLETED ON: 05/07/2018.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS COMPLETED ON: 05/07/2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS (ALARM 29 - MOTOR CART RANGE LOW) OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. BLOOD GLUCOSE WAS 150 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTION AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106871 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR