BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS:180 PSA2

    MDR report key: 108071 · Received July 22, 1997

    Report

    Report Number
    1219913-1997-00001
    Event Type
    Malfunction
    Date Received
    July 22, 1997
    Report Date
    July 14, 1997
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Product Code
    LTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BOTTLE TO BOTTLE VARIATIONS IN THE ACS:180 PSA2 ASSAY (LOTS 13, 17, AND 18) LITE REAGENT HAVE BEEN OBSERVED ON IN-HOUSE TESTING WHICH MAY CONTRIBUTE TO ERRONEOUS RESULTS THAT ARE EITHER TOO HIGH OR TOO LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS:180 PSA2 IMMUNOASSAY LTJ CHIRON DIAGNOSTICS CORP. NA 53L13, 53L17, 53L18

    Patients

    Seq Age Sex Outcome Treatment
    1 NA