BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO HCV 3.0 ELISA TEST SYSTEM

    MDR report key: 1522876 · Received October 30, 2009

    Report

    Report Number
    2250051-2009-00317
    Event Type
    Other
    Date Received
    October 30, 2009
    Date of Event
    October 2, 2009
    Report Date
    October 29, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT A FALSE NEGATIVE RESULT OCCURRED WITH ONE SAMPLE TESTED FOR HCV. SAMPLE WAS TESTED AND RESULTED IN AN INITIAL REACTIVE RESULT FOR THE ORTHO HCV 3.0 ELISA. REPEAT TESTING WAS PERFORMED IN DUPLICATE AND BOTH RESULTS OBTAINED WERE NON REACTIVE. SAMPLE ALSO TESTED POSITIVE ON CUSTOMER NAT TESTING. CUSTOMER REPEATED THE TESTING ON ONE OF THE TWO BLOOD BAGS AVAILABLE FROM THE DONATION AND GOT A REACTIVE RESULT. OCD PERFORMED SMT.LOG FILE ANALYSIS AND NO INSTRUMENT ERRORS WERE IDENTIFIED. ALL ASSAY VALIDITY CRITERIA WERE MET FOR THE RUN. NO USER ERRORS WERE REPORTED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. A COMPLAINT REVIEW INDICATED NO OTHER SIMILAR COMPLAINTS HAVE BEEN LOGGED AGAINST THIS LOT. BATCH RECORD REVIEW INDICATED KIT LOT MET ALL QA RELEASE CRITERIA. NO INCORRECT RESULTS WERE REPORTED OUT. CUSTOMER SUCCESSFULLY REPEATED THE SAMPLES IN QUESTION.

    Description of Event or Problem · 1

    THE ORTHO HCV VERSION 3.0 ELISA TEST SYSTEM LOT# TXE520 REPORTEDLY GENERATED A FALSE NEGATIVE RESULT. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO HCV 3.0 ELISA TEST SYSTEM EIA DONOR SCREENING ASSAY MZO ORTHO-CLINICAL DIAGNOSTICS, INC. NA TXE520

    Patients

    Seq Age Sex Outcome Treatment
    1