BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11252135 · Received January 29, 2021

    Report

    Report Number
    3013756811-2021-09994
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 29, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT A CARTRIDGE ALARM 1 INTERMITTENTLY OCCURRED WITH MULTIPLE CARTRIDGES DURING BOLUS DELIVERIES. IN ADDITION, THE INSULIN GAUGE WAS INACCURATE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 130-337 MG/DL. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151656 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 M681483 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR