BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 14111463 · Received April 14, 2022

    Report

    Report Number
    3013756811-2022-35216
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 13, 2022
    Report Date
    March 24, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE CARTRIDGE TUBING. CUSTOMER PERFORMED A SUPPLY CHANGE TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 220-270 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133524 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 60310105 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male