BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11203448 · Received January 20, 2021

    Report

    Report Number
    3013756811-2021-06043
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 8, 2020
    Report Date
    January 20, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S USER GUIDE: ¿CHECK THAT YOUR CONNECTION BETWEEN THE CARTRIDGE TUBING AND THE INFUSION SET TUBING IS TIGHT AND SECURE.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LUER LOCK BECAME DISCONNECTED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 230-500 MG/DL. A CARTRIDGE CHANGE WAS PERFORMED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100473 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR