BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8675383 · Received June 6, 2019

    Report

    Report Number
    3013756811-2019-32435
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    April 27, 2019
    Report Date
    June 6, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CARTRIDGE AIR BUBBLES WERE OBSERVED THROUGHOUT THE INFUSION SET TUBING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200-260 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP AND SUPPLIES FOR INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468635 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 5 YR INSULIN: NOVOLOG/NOVORAPID