BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT

    MDR report key: 4200018 · Received October 24, 2014

    Report

    Report Number
    3007111389-2014-00231
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT REPRODUCIBLE, DISCORDANT (B)(6) RESULTS WERE OBTAINED FROM A SINGLE BIO-RAD EQ AS PROFICIENCY SAMPLE TESTED ON A VITRO'S ECI INSTRUMENT, WHEN COMPARED TO (B)(6) RESULTS OBTAINED USING TWO DIFFERENT NON-VITRO'S METHODS. THE ASSIGNABLE CAUSE FOR THE EVENT IS UNKNOWN; HOWEVER, AN UNKNOWN SAMPLE INTERFERENT COULD NOT BE RULED OUT. A REAGENT OR INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED REPRODUCIBLE, DISCORDANT (B)(6) RESULTS WERE OBTAINED FROM A SINGLE BIO-RAD EQ AS PROFICIENCY SAMPLE TESTED ON A VITRO'S ECI INSTRUMENT, WHEN COMPARED TO (B)(6) REACTIVE RESULTS OBTAINED USING TWO DIFFERENT NON-VITRO'S METHODS. THERE WAS NO REPORT OF AFFECTED PATIENT SAMPLES; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679243 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 3480

    Patients

    Seq Age Sex Outcome Treatment
    1