BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14167173 · Received April 21, 2022

    Report

    Report Number
    3013756811-2022-41678
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 1, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER CHANGED ALL SUPPLIES IN AN ATTEMPT TO RESOLVE THE ISSUE, HOWEVER, NO INSULIN DRIPS WERE OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. A SUPPLY CHANGE WAS PERFORMED TO RESOLVE THE ISSUE AND INSULIN DELIVERY WAS SUCCESSFULLY RESUMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 221-300 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770749 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male