BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT

    MDR report key: 2000683 · Received February 24, 2011

    Report

    Report Number
    3007111389-2011-00016
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT REPRODUCIBLE, FALSE NEGATIVE VITROS ANTI-HBC IGM RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHILE USING THE VITROS 3600 ANALYZER. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED, HOWEVER, THE HISTORY AND CONDITION OF THE SAMPLES THEMSELVES CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE TRUE CLASSIFICATION OF THE SAMPLES IS BELIEVED TO BE POSITIVE (REACTIVE) BASED UPON RESULTS OBTAINED FROM TWO SEPARATE NON-VITROS REAGENT METHODS. ACCEPTABLE RESULTS WERE OBTAINED WHEN FRESHLY DRAWN SAMPLES WERE USED IN THE CORRELATION TEST. THERE IS NO INDICATION THE VITROS 3600 SYSTEM WAS NOT OPERATING AS INTENDED.

    Description of Event or Problem · 1

    AN (B)(6) LABORATORY SPECIALIST OBSERVED MULTIPLE REPRODUCIBLE, FALSE NEGATIVE ANTI-HBC IGM RESULTS ON MULTIPLE PATIENT SAMPLES ON THE VITROS 3600 ANALYZER, DURING A CORRELATION WITH TWO SEPARATE NON-VITROS SYSTEMS. FALSE NEGATIVE RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE NEGATIVE VITROS RESULTS WERE NOT REPORTED, AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SEVEN OF EIGHT MDR'S FOR THIS EVENT. EIGHT 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS EIGHT DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 6570

    Patients

    Seq Age Sex Outcome Treatment
    1