BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18354802 · Received December 19, 2023

    Report

    Report Number
    3013756811-2023-177800
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 27, 2023
    Report Date
    June 24, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5.

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED UNEXPECTED SHUTDOWN ISSUE WAS VERIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED. THE WAKE BUTTON ISSUE COULD NOT BE VERIFIED.

    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 SHUT OFF UNEXPECTEDLY. ADDITIONALLY, IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. CUSTOMER PRESSED THE WAKE BUTTON MULTIPLE TIMES AND THE WAKE BUTTON PERFORMED AS INTENDED. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 232-233 MG/DL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. ADDITIONALLY, IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 232-233 MG/DL. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350137 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown