BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13513412 · Received February 11, 2022

    Report

    Report Number
    3013756811-2022-13664
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 25, 2022
    Report Date
    February 11, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007998
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 MULTIPLE OCCLUSION ALARMS OCCURRED INTERMITTENTLY. THE CUSTOMER TROUBLESHOT AND PERFORMED A SUPPLY CHANGE; HOWEVER, NO CAUSE WAS DETERMINED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150-190 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81675 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 M983762 00853052007998

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INFUSION SET: AUTOSOFT 90INSULIN: NOVOLOG / NOVOR