BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 4898784 · Received July 8, 2015

    Report

    Report Number
    3007111389-2015-00198
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    May 30, 2015
    Report Date
    July 8, 2015
    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 DETERMINED THAT DISCORDANT (B)(6) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED WITH VITROS AHCV REAGENT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM COMPARED TO REACTIVE RESULTS FROM NON-VITROS METHODS. ROOT CAUSE FOR THE UNEXPECTED REPRODUCIBLE (B)(6) VITROS AHCV RESULTS COULD NOT BE DETERMINED; HOWEVER, THE POSSIBILITY THAT AN UNKNOWN SAMPLE INTERFERENT, AN UNEXPECTED VITROS AHCV REAGENT PERFORMANCE OR INAPPROPRIATE PRE-ANALYTICAL SAMPLE PROCESSING HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED DISCORDANT, REPRODUCIBLE, (B)(6) RESULTS FROM A SINGLE PATIENT SAMPLE WHEN TESTED WITH VITROS AHCV REAGENT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM COMPARED TO REACTIVE RESULTS FROM NON-VITROS METHODS. PATIENT SAMPLE RESULTS: 0.06, 0.07 S/C VS EXPECTED >=1.00 S/C BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE (B)(6) RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND A CORRECTED REPORT WAS LATER ISSUED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443726 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 3590

    Patients

    Seq Age Sex Outcome Treatment
    1