BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13367377 · Received January 27, 2022

    Report

    Report Number
    3013756811-2022-10357
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 18, 2022
    Report Date
    January 18, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00085006613373
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. ADDITIONALLY, IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE O-RING. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 151-182 MG/DL. REPORTEDLY, THE CUSTOMER SUCCESSFULLY LOADED A NEW CARTRIDGE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259065 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 M625947 00085006613373

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male