BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT

    MDR report key: 2082253 · Received May 9, 2011

    Report

    Report Number
    3007111389-2011-00050
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT DISCORDANT NEGATIVE VITROS HBSAG RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, SAMPLE HANDLING, SAMPLE AGE, AND SAMPLE STORAGE CONDITIONS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED DISCORDANT NEGATIVE VITROS HBSAG RESULTS (0.53, 0.88, 0.88) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE PATIENT SAMPLE WAS CONSIDERED TO BE HBSAG REACTIVE BASED ON RESULTS OBTAINED FROM AN ALTERNATE VITROS ANALYZER (1.10, 1.01, 0.76, 1.01) AND CONFIRMATORY TESTING. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT NEGATIVE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO 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 HBSAG REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 7000

    Patients

    Seq Age Sex Outcome Treatment
    1