BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18535654 · Received January 18, 2024

    Report

    Report Number
    3013756811-2024-12342
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 18, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. DURING TROUBLESHOOTING DEBRIS WAS IDENTIFIED ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE DEBRIS FROM THE PUMP AND CHANGED THE PUMP SUPPLIES TO ADDRESS THE ISSUES. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 203-244 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759098 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female INFUSION SET: AUTOSOFT XC.INSULIN TYPE: HUMALOG.