BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21919507 · Received April 28, 2025

    Report

    Report Number
    3013756811-2025-81474
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 25, 2025
    Report Date
    April 28, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 210 UNITS OF INSULIN DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT THE CARTRIDGE O-RING WAS MISSING. THE CUSTOMER CONFIRMED THE O-RING WAS NOT LOCATED ON THE PNEUMATIC TAP. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 210-240 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222863 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 W1304348 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male