BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17818226 · Received September 26, 2023

    Report

    Report Number
    3013756811-2023-132532
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 30, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED ALTITUDE ALARM ISSUE WAS VERIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED WHILE BASED ON THE ANALYSIS, THE ALLEGED - LOAD SEQUENCE ISSUE COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. SUBSEQUENTLY, IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IN 191-200 MG/DL RANGE. REPORTEDLY, THE CUSTOMER CONTACTED THE HEALTHCARE PROVIDER TO OBTAIN ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973530 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male INSULIN: HUMALOG