BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14205454 · Received April 26, 2022

    Report

    Report Number
    3013756811-2022-42201
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 6, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN DRIPS WERE INTERMITTENTLY NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. REPORTEDLY, MULTIPLE SUPPLY CHANGES WERE PERFORMED TO ADDRESS THE ISSUES; HOWEVER, THE ISSUE PERSISTED, AND THE CUSTOMER REVERTED BACK TO MANUAL DAILY INJECTIONS. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 110-193 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032694 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0242481 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female INSULIN: LISPROINFUSION SET: TRUSTEEL