BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARTELS ELISA LEGIONELLA URINIARY ANTIGEN

    MDR report key: 12787010 · Received November 10, 2021

    Report

    Report Number
    1318354-2021-00003
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 4, 2021
    Manufacturer
    TRINITY BIOTECH, USA
    Product Code
    MJH
    UDI-DI
    05391516744065
    PMA / PMN Number
    K991074
    Removal / Correction Number
    1318354-11/04/2021-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LABORATORY USER INFORMED MANUFACTURER THAT THEIR NEW SHIPMENT OF LUA KITS B1029-440 LOT 056 WAS FOUND TO HAVE SOME SORT OF GEL/PRECIPITATE IN EVERY BOTTLE OF CONJUGATE.

    Description of Event or Problem · 0

    LABORATORY USER INFORMED MANUFACTURER THAT THEIR NEW SHIPMENT OF LUA KITS B1029-440 LOT 056 WAS FOUND TO HAVE SOME SORT OF GEL/PRECIPITATE IN EVERY BOTTLE OF CONJUGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682910 BARTELS ELISA LEGIONELLA URINIARY ANTIGEN LEGIONELLA URINARY ANTIGEN MJH TRINITY BIOTECH, USA B1029-440 056 05391516744065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown