BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT

    MDR report key: 3222592 · Received July 12, 2013

    Report

    Report Number
    3007111389-2013-00133
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    April 10, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, REPRODUCIBLE, UNEXPECTED NEGATIVE VITROS ANTI-HBC RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 3600 SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. AN UNKNOWN SAMPLE INTERFERENT CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, UNEXPECTED NEGATIVE, VITROS (B)(6) RESULTS FOR A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 3600 SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: PATIENT (VITROS) RESULT = (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF HARM TO PATIENT 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
    324284 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 1855

    Patients

    Seq Age Sex Outcome Treatment
    1