BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 2883939 · Received December 21, 2012

    Report

    Report Number
    3007111389-2012-00265
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE REPRODUCIBLE, (B)(6) RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES 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, A VARIATION IN PERFORMANCE BETWEEN THE 3600 AND ECI ANALYZER CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE REPRODUCIBLE, (B)(6) RESULTS FROM TWO DIFFERENT PATIENT SAMPLES WHILE USING THE VITROS 3600 SYSTEM. (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE AFFECTED RESULTS WERE NOT REPORTED FROM THE LABORATORY AS THEY WERE REPEAT TESTED ON A VITROS ECI ANALYZER. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 8730

    Patients

    Seq Age Sex Outcome Treatment
    1