BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12984308 · Received December 13, 2021

    Report

    Report Number
    3013756811-2021-139458
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 26, 2021
    Report Date
    December 13, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INTERMITTENTLY, INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE INFUSION SET TUBING DURING THE LOAD FILL TUBING PROCESS. REPORTEDLY, MULTIPLE SUPPLY CHANGES WERE PERFORMED TO ADDRESS THE ISSUES AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE WAS APPROXIMATELY 100-142 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887385 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0228793 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male INSULIN: HUMALOGINFUSION SET: AUTOSOFT XC