BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHLAMYDIAZYME EIA

    MDR report key: 489418 · Received October 9, 2003

    Report

    Report Number
    1415939-2003-00020
    Event Type
    Other
    Date Received
    October 9, 2003
    Date of Event
    September 10, 2003
    Report Date
    October 8, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED NEGATIVE CHLAMYDIAZYME EIA RESULTS, REAGENT LOT 04572M100, ON 18 PTS THAT TESTED BSA SLIDE TECHNIQUE POSITIVE. THIS REPORT IS FOR PT 12 OF THE 18 TOTAL PTS. ALTHOUGH THE CONTROL VALUES WERE ACCEPTABLE, THE ACCOUNT NOTICED A BIG DROP IN THE POSITIVE RESULT VALUES AS COMPARED TO THE USUAL OBSERVED POSITIVE RESULT VALUES. THE ACCOUNT RETESTED THE PTS USING CHLAMYDIAZYME EIA REAGENT LOT 03228M100 WITH THE EXPECTED POSITIVE RESULTS. AMENDED REPORTS WERE SUBMITTED TO THE PHYSICIANS. IT IS UNKNOWN IF THERE WAS IMPACT TO PT MANAGEMENT. NO PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHLAMYDIAZYME EIA EIA FOR THE DETECTION OF CHLAMYDIA ANTIGEN LJC ABBOTT LABORATORIES NA 04572M100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN QUANTUM II ANALYZER LIST 3303-13.