BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15959006 · Received December 12, 2022

    Report

    Report Number
    3013756811-2022-141428
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 12, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER TANDEM USER GUIDE: USE ONLY SINGLE-USE, DISPOSABLE T:SLIM CARTRIDGES. THE EFFICACY OF YOUR T:SLIM PUMP CANNOT BE GUARANTEED IF CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. ARE USED OR IF CARTRIDGES ARE FILLED MORE THAN ONCE. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER-INFUSION OR UNDER-INFUSION AND MAY CAUSE SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, CUSTOMER REFILLED THE CARTRIDGE. CUSTOMER RELOADED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMERS BLOOD GLUCOSE LEVEL WAS 270 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130298 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female INSULIN: NOVOLOG/NOVORAPID.INFUSION SET: AUTOSOFT.