BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22726107 · Received August 6, 2025

    Report

    Report Number
    3013756811-2025-185851
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 11, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K232380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL PROCESS. REPORTEDLY, A SUPPLY CHANGE WAS PERFORMED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE WAS BETWEEN 222-417 MG/DL.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A PAST HIGH BLOOD GLUCOSE EVENT WITH THE EXACT HIGH VALUE UNKNOWN, THOUGH IT WAS INDICATED AS "HIGH." CAUSE WAS NOT KNOWN. TO RESOLVE THE HIGH BLOOD GLUCOSE, THE CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA THE PUMP WHILE THE CONTROL IQ FEATURE WAS ACTIVE. MOREOVER, AS RECURRING HIGH BLOOD GLUCOSE LEVELS OCCURRED, CUSTOMER TECHNICAL SUPPORT TRANSFERRED THE CALL AND REQUESTED FOLLOW-UP FOR ADDITIONAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528838 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female