BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11948053 · Received June 7, 2021

    Report

    Report Number
    3013756811-2021-58169
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 16, 2021
    Report Date
    June 7, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS OCCURRED DURING THE LOAD SEQUENCE AND DURING BASAL INSULIN DELIVERY WITH DIFFERENT CARTRIDGES. ADDITIONALLY, IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED. CUSTOMER REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 231-300 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845377 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 M831825 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INFUSION SET: AUTOSOFT XC, INSULIN: HUMALOG| INFUSION SET: AUTOSOFT XC, INSULIN: HUMALOG