BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17277845 · Received July 7, 2023

    Report

    Report Number
    3013756811-2023-90671
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 7, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE TANDEM USER GUIDE - THE DISPOSABLE CARTRIDGE IS FILLED WITH UP TO 300 UNITS OF U-100 INSULIN AND ATTACHED TO THE PUMP. THE CARTRIDGE IS REPLACED EVERY 48¿72 HOURS. PER THE TANDEM USER GUIDE - THE DISPOSABLE CARTRIDGE IS FILLED WITH UP TO 300 UNITS OF U-100 INSULIN AND ATTACHED TO THE PUMP. THE CARTRIDGE IS REPLACED EVERY 48¿72 HOURS. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONGOING OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER HAD BEEN USING THE SAME CARTRIDGE AND INFUSION SET FOR OVER 3 DAYS USING NOVOLOG INSULIN. ADDITIONALLY, CUSTOMER WAS OVERFILLING CARTRIDGES. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT NOVOLOG INSULIN IS INDICATED FOR USE WITH TANDEM SUPPLIES FOR 3 DAYS. CUSTOMER CHANGED CARTRIDGE AND INFUSION SET TO ADDRESS THE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612400 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLE INFUSION PUMP QFG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male INSULIN: NOVOLOG/NOVORAPID