BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14592090 · Received June 3, 2022

    Report

    Report Number
    3013756811-2022-56373
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 16, 2022
    Report Date
    May 16, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AN OCCLUSION ALARM OCCURRED. CUSTOMER CLEARED THE ALARM AND REPORTED THAT THE PUMP SUPPLIES WOULD BE CHANGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 201-292 MG/DL. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834037 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male INFUSION SET: TRUSTEELINSULIN: HUMALOG