BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 7453942 · Received April 24, 2018

    Report

    Report Number
    3007111389-2018-00057
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 5, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT DISCORDANT NEGATIVE RESULTS WERE OBTAINED FOR A SINGLE PATIENT PROCESSED USING VITROS ANTI-HCV REAGENT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (S/N (B)(4)). THE ASSIGNABLE CAUSE IS UNKNOWN. A CALIBRATION ISSUE, SAMPLE STORAGE ISSUE, OR PRE-ANALYTICAL SAMPLE HANDLING COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE INSTRUMENT AND/OR THE REAGENT WERE NOT PERFORMING AS EXPECTED AS QUALITY CONTROL FLUID RESULTS WERE REPORTED AS ACCEPTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED DISCORDANT NEGATIVE RESULTS OBTAINED FOR A SINGLE PATIENT, PROCESSED USING VITROS ANTI-HCV REAGENT ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS AHCV RESULTS 0.73, 0.59, 0.58, 0.67, 0.67 S/C (NEGATIVE) VERSUS EXPECTED RESULTS OF 1.04, 1.23 (REACTIVE). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE DISCORDANT NEGATIVE RESULTS WERE NOT REPORTED FROM THE LABORATORY. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBER (B)(4)/QERTS RECORD ID (B)(4). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296007 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 4200

    Patients

    Seq Age Sex Outcome Treatment
    1