BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 9806303 · Received March 9, 2020

    Report

    Report Number
    3013756811-2020-22501
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 9, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00852162004781
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 RESISTANCE WAS EXPERIENCED DURING THE FILL PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 118-180 MG/DL. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270343 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INFUSION SET: TRUSTEELINSULIN TYPE: NOVOLOG