BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14268893 · Received May 3, 2022

    Report

    Report Number
    3013756811-2022-45313
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 12, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED, INDICATING CUSTOMER'S BLOOD GLUCOSE WAS 250-370 MG/DL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING AT THE SEPTUM, THE O-RING, AND THE PATIENT LINE. CUSTOMER LOADED A NEW CARTRIDGE TO ADDRESS THE ISSUE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374909 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 52 YR Male