BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18960407 · Received March 22, 2024

    Report

    Report Number
    3013756811-2024-46482
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 22, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE IDENTIFIED. CUSTOMER CHANGED THE PUMP SUPPLIES AND RESUMED INSULIN DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 232-300 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524677 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female