BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18985599 · Received March 27, 2024

    Report

    Report Number
    3013756811-2024-49355
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 30, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319513
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED, AND EVALUATION IS PERFORMED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. ADDITIONALLY, A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 190 UNITS OF INSULIN. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 190-230 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494327 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0945775 00389152319513

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male