BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15395915 · Received September 9, 2022

    Report

    Report Number
    3013756811-2022-97042
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 19, 2022
    Report Date
    August 19, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00852162004781
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 MALFUNCTION ALARM OCCURRED. REPORTEDLY, THE MALFUNCTION ALARM WAS CLEARED AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. SUBSEQUENTLY AFTER THE PUMP RESET, THE PUMP TIME AND DATE BECAME INACCURATE. THE CUSTOMER CORRECTED THE TIME AND DATE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140-263 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819950 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female