BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14858755 · Received June 29, 2022

    Report

    Report Number
    3013756811-2022-68023
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 11, 2022
    Report Date
    June 11, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, BUT A TEMPERATURE ALARM OCCURRED. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. 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. REPORTEDLY, THE CUSTOMER SUCCESSFULLY LOADED A NEW CARTRIDGE TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 - 227 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089953 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female