BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16769441 · Received April 19, 2023

    Report

    Report Number
    3013756811-2023-54942
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    January 31, 2023
    Report Date
    June 14, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 130-142 MG/DL. CUSTOMER SUCCESSFULLY RESUMED INSULIN THERAPY ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520201 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 M945156 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female INFUSION SET: AUTOSOFT 90INSULIN TYPE: NOVOLOG/ N