BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 20546142 · Received October 28, 2024

    Report

    Report Number
    3013756811-2024-202013
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 28, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 AN O-RING WAS ON THE PNEUMATIC TAP. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE. THE DISTRIBUTOR RECEIVED THE PUMP FOR INVESTIGATION AND WAS UNABLE TO DUPLICATE THE ERROR. THERE WAS NO O-RING ON THE PNEUMATIC TAP AND A NEW CARTRIDGE WAS LOADED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020981 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown