BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16353337 · Received February 10, 2023

    Report

    Report Number
    3013756811-2023-16298
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 10, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER RELOADED THE CARTRIDGE TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BASAL DELIVERY. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN 140-189 MG/DL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161687 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male