BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14218230 · Received April 27, 2022

    Report

    Report Number
    3013756811-2022-41850
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 8, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT MALFUNCTION ALARMS OCCURRED. REPORTEDLY THE CUSTOMER HAD AN ALTERNATE PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 140-225 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970099 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female