BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICE PRODUCTS ANTI-HBS REAGENT

    MDR report key: 2083507 · Received May 10, 2011

    Report

    Report Number
    3007111389-2011-00052
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT REACTIVE VITROS ANTI-HBS RESULT FOR A SINGLE PATIENT SAMPLE WAS OBTAINED DURING A PATIENT CORRELATION STUDY. NO VITROS ANTI-HBS REAGENT OR VITROS 3600 INSTRUMENT RELATED MALFUNCTIONS WERE OBSERVED AT THE TIME OF THE EVENT. THE DEFINITIVE ROOT CAUSE OF THIS EVENT IS UNKNOWN. HOWEVER, A COMBINATION OF SAMPLE HANDLING, AGE OF THE SAMPLE, AND SAMPLE STORAGE CONDITIONS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A DISCORDANT REACTIVE VITROS ANTI-HBS RESULT (16.8 MIU/ML, REACTIVE) FOR A SINGLE PATIENT SAMPLE DURING A PATIENT CORRELATION STUDY PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN COMPARED TO AN ALTERNATE VITROS ANALYZER. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULT WAS NOT REPORTED OUT OF THE LABORATORY BECAUSE TESTING PERFORMED WAS FOR THE CORRELATION STUDY ONLY. THE ALTERNATE ANALYZER PATIENT RESULT WAS 0.1 MIU/ML (NEGATIVE). THERE WAS NO REPORT OF 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 IMMUNODIAGNOSTICE PRODUCTS ANTI-HBS REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 6160

    Patients

    Seq Age Sex Outcome Treatment
    1