BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO HCV TEST KIT

    MDR report key: 435047 · Received December 20, 2002

    Report

    Report Number
    2250051-2002-00713
    Event Type
    Malfunction
    Date Received
    December 20, 2002
    Date of Event
    December 9, 2002
    Report Date
    December 18, 2002
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LQI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PROCESSING AN HCV PLATE ON ORTHO SUMMIT PROCESSOR THE CUSTOMER REPORTED NEGATIVE ABSORBANCES IN ROW H OF A SINGLE MICROWELL PLATE. NO ERROR WAS REPORTED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO HCV TEST KIT ELISA TEST KIT LQI ORTHO-CLINICAL DIAGNOSTICS 7003009 TXE349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other