BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14853379 · Received June 29, 2022

    Report

    Report Number
    3013756811-2022-64730
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 8, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED CARTRIDGE ALARM ISSUES WERE VERIFIED. BASED ON THE ANALYSIS, THE ALLEGED INSULIN GAUGE ISSUE COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS OCCURRED DURING INSULIN DELIVERY WITH MULTIPLE CARTRIDGES. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUES. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110-240 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366119 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60329222 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF