BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15564602 · Received October 7, 2022

    Report

    Report Number
    3013756811-2022-110360
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 14, 2022
    Report Date
    December 8, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. THE CUSTOMER'S BLOOD GLUCOSE WAS 130 - 300 MG/DL. A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800639 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female