BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT

    MDR report key: 2883659 · Received December 21, 2012

    Report

    Report Number
    3007111389-2012-00261
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    September 27, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A REPRODUCIBLE, (B)(6) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 3600 SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. HOWEVER, THE POSSIBILITY OF THE PRESENCE OF A (B)(6), THAT IS NOT RECOGNIZED BY THE VITROS HBSAG ASSAY, CANNOT BE RULED OUT AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A REPRODUCIBLE, (B)(6) FROM A SINGLE PATIENT SAMPLE WHILE USING THE VITROS 3600 SYSTEM. IT IS UNKNOWN IF THE (B)(6) RESULTS WERE REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE SAMPLE WAS REPEATED USING TWO DIFFERENT ALTERNATE SYSTEMS FOR UNKNOWN REASONS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT IN-VITRO DIAGNOSTIC LOM ORTHO-CLINICAL DIAGNOSTICS 7180

    Patients

    Seq Age Sex Outcome Treatment
    1