BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14776893 · Received June 22, 2022

    Report

    Report Number
    3013756811-2022-65374
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    June 5, 2022
    Report Date
    June 5, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 06 OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE OF THE ALLOWABLE OPERATING ALTITUDE RANGE AT THE TIME OF THIS ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 153 - 190 MG/DL. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND REVERTED TO A BACK UP PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241218 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60342244 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male