BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10606707 · Received September 30, 2020

    Report

    Report Number
    3013756811-2020-106521
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 16, 2020
    Report Date
    September 30, 2020
    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 · 1

    PER TANDEM USER GUIDE: "DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE." 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 AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER ACCIDENTALLY REFILLED A USED CARTRIDGE. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE LABELING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 150-171 MG/DL. SUBSEQUENTLY, WHILE THE CUSTOMER WAS FILLING THE TUBING, CUSTOMER NOTICED THAT THE CARTRIDGE PIGTAIL "APPEARED TO BE WET." CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073534 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR INSULIN: HUMALOG, INFUSION SET: AUTOSOFT XC