BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11437865 · Received March 8, 2021

    Report

    Report Number
    3013756811-2021-28395
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 8, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007271
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THE BATTERY GAUGE WAS FLUCTUATING WHICH RESULTED IN THE PUMP SHUTTING DOWN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 240-247 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333687 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007271

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR