BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13417773 · Received February 1, 2022

    Report

    Report Number
    3013756811-2022-13735
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 9, 2022
    Report Date
    January 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THE CUSTOMER RECEIVED A POWER SOURCE ALERT AND THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, A CARTRIDGE ALARM 1 OCCURRED DURING THE LOAD SEQUENCE AND AN ALTITUDE ALARM OCCURRED. IT WAS ALSO REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH XXX UNITS OF INSULIN DURING THE LOAD SEQUENCE. THE CUSTOMER WAS UNABLE TO RESOLVE THE ISSUES AND REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BETWEEN 200-334 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486571 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 WD197823 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female