BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18355053 · Received December 19, 2023

    Report

    Report Number
    3013756811-2023-181952
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 26, 2023
    Report Date
    December 19, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AVOID EXPOSURE OF YOUR PUMP TO TEMPERATURES BELOW 41°F (5°C) OR ABOVE 99°F (37°C). INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. INSULIN THAT HAS BEEN EXPOSED TO CONDITIONS OUTSIDE OF THE MANUFACTURER¿S RECOMMENDED RANGES CAN AFFECT THE SAFETY AND PERFORMANCE OF THE PUMP. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY THE CUSTOMER IS USING COLD INSULIN. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT USING COLD INSULIN, IS OFF LABEL PER THE USER GUIDE. CUSTOMER'S BLOOD GLUCOSE LEVEL (BG) WAS 151-224 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350151 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 6002031 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female INFUSION SET: AUTOSOFT XC.INSULIN: NOVOLOG.