BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9348846 · Received November 20, 2019

    Report

    Report Number
    3013756811-2019-81796
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    November 6, 2019
    Report Date
    November 20, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MET WHILE LOADING CARTRIDGE WITH INSULIN AND THE INSULIN GAUGE WAS INACCURATE. CUSTOMER CHANGE OUT THE SYRINGE NEEDLE AND RELOADED THE CARTRIDGE TO RESOLVE THE ISSUES. CUSTOMER'S BLOOD GLUCOSE WAS 240-247 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142474 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR