BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT

    MDR report key: 2863415 · Received December 10, 2012

    Report

    Report Number
    3007111389-2012-00247
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 6, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT POSITIVE VITROS ANTI-HBS RESULT WAS OBTAINED FROM A KNOWN NEGATIVE PROFICIENCY SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT MALFUNCTION OCCURRED. EXPECTED RESULTS WERE OBTAINED UPON REPEAT TESTING OF THE SAME SAMPLE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, PRE-ANALYTICAL SAMPLE MIX-UP CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    AN OCD LABORATORY SPECIALIST REPORTED A DISCORDANT VITROS ANTI-HBS RESULT ((B)(6) ) FROM A PROFICIENCY SAMPLE RUN ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IS THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATENT SAMPLE RESULTS OR PATIENT HARM AS A RESULT OF THIS EVENT. 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-HBS QUANTITATIVE REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 6600

    Patients

    Seq Age Sex Outcome Treatment
    1