BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16435669 · Received February 24, 2023

    Report

    Report Number
    3013756811-2023-26177
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 3, 2023
    Report Date
    February 24, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 250 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. CUSTOMERS BLOOD GLUCOSE LEVEL WAS 120-399 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859465 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0783082 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female INSULIN: HUMALOG.INFUSION SET: AUTOSOFT XC.