BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK

    MDR report key: 1151015 · Received August 28, 2008

    Report

    Report Number
    9680658-2008-00258
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    March 6, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE FALSE NEGATIVE HBSAG RESULTS WAS DETERMINED TO BE A MUTANT STRAIN OF HEPATITIS. THE DEVICE LABELING, LOCATED IN THE LIMITATIONS SECTION OF THE VITROS HBSAG INSTRUCTION FOR USE STATES: "HBSAG RESULTS SHOULD ONLY BE USED AND INTERPRETED IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HEPATITIS B VIRUS. LEVELS OF HBSAG MAY BE UNDETECTABLE BOTH IN EARLY INFECTION AND LATE AFTER INFECTION. IN RARE CASES, HBSAG TESTS DO NOT DETECT CERTAIN HBV MUTANT STRAINS."

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED REPRODUCIBLE, FALSE NEGATIVE VITROS HBSAG RESULTS FROM A SINGLE PT TESTED ON THE VITROS ECI ANALYZER ON MULTIPLES DATES IN 2008. OTHER HEPATITIS ASSAYS (INCLUDING VITROS HBEAG) PERFORMED AT THE SAME TIME PRODUCED POSITIVE RESULTS FOR HEPATITIS B. FALSE NEGATIVE RESULTS COULD RESULT IN INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. NOTE: THIS FORM 3500A (MDR# 9680658-2008-00258) IS FOUR OF FIVE MDRS FOR THIS EVENT. FIVE DEVICES WERE INVOLVED. FIVE SAMPLES FROM THE SAME PT WERE ASSAYED TO RULE OUT THE PRESENCE OF AN INTERFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS NA 2000

    Patients

    Seq Age Sex Outcome Treatment
    1