BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14118207 · Received April 15, 2022

    Report

    Report Number
    3013756811-2022-35061
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 22, 2022
    Report Date
    March 23, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 OCCLUSION ALARMS OCCURRED. ADDITIONALLY, AIR BUBBLES WERE OBSERVED ALONG THE INFUSION SET TUBING. CUSTOMERS BLOOD GLUCOSE WAS IN THE RANGE OF 250-296 MG/DL. REPORTEDLY, THE CUSTOMER REPLACED THE PUMP SUPPLIES AND RESUMED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137016 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female INFUSION SET: AUTOSOFT 30INSULIN: NOVOLOG