BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16303703 · Received February 6, 2023

    Report

    Report Number
    3013756811-2023-21982
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 1, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 PUMP TOUCH SCREEN WAS CRACKED AND UNREADABLE. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE. AS WELL, AS THAT A CARTRIDGE CHANGE ERROR OCCURRED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110-133 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD IN INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137517 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 45 YR Female