BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19959897 · Received August 12, 2024

    Report

    Report Number
    3013756811-2024-140633
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 20, 2024
    Report Date
    August 28, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/B5.JSF# PER THE TANDEM USER GUIDE: ACCESSORIES FOR CHARGING FROM WALL OUTLETS, AS WELL AS FROM A COMPUTER USB PORT, ARE INCLUDED WITH THE PUMP. USE ONLY THE ACCESSORIES PROVIDED TO CHARGE YOUR PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS HOT TO TOUCH WHILE CHARGING. REPORTEDLY, THE CUSTOMER WAS USING NON-TANDEM CHARGING SUPPLIES TO CHARGE THE PUMP. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028701 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 72 YR Female