BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18741063 · Received February 20, 2024

    Report

    Report Number
    3013756811-2024-23640
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 20, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PER TANDEM USER GUIDE: "THE CARTRIDGE IS INDICATED AS A RESERVOIR FOR THE DELIVERY OF RAPID-ACTING INSULIN WITH THE T:SLIM PUMP. HUMALOG® AND NOVOLOG® HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC. AND FOUND TO BE SAFE FOR USE IN THE T:SLIM PUMP. HUMALOG® WAS TESTED FOR UP TO 48 HOURS AS LABELED, NOVOLOG® WAS TESTED FOR UP TO 72 HOURS." THE TANDEM PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE AND STATIC. REPORTEDLY, THE CUSTOMER USED THE CARTRIDGE BEYOND LABELING AND DID NOT PERFORM THE AIR REMOVAL STEP CORRECTLY. CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377638 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W1173122 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female INSULIN TYPE: HUMALOGINFUSION SET: AUTOSOFT 90