BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HCV II

    MDR report key: 23159123 · Received September 26, 2025

    Report

    Report Number
    1823260-2025-03889
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 6, 2022
    Report Date
    September 26, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZO
    PMA / PMN Number
    P140021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANTI-HCV II REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE REPORTED EVENT OCCURRED ON A COBAS E 801 ANALYZER (SERIAL NUMBER: (B)(6).. THE INVESTIGATION DETERMINED THAT THE ELECSYS ANTI-HCV ASSAY PERFORMED WITHIN SPECIFICATIONS. CALIBRATION AND QUALITY CONTROL DATA WERE REVIEWED AND FOUND TO BE WITHIN EXPECTED RANGES. ADDITIONAL TESTING OF THE SURVEY SAMPLE USING THE FUJIREBIO INNOLIA HCV SCORE YIELDED A NEGATIVE RESULT, WHILE THE ELECSYS ANTI-HCV ASSAY RESULT WAS REACTIVE (1.02 COI). THE DISCREPANCY WAS ATTRIBUTED TO A NONSPECIFIC FALSE REACTIVE RESULT, WHICH IS COVERED BY THE ASSAY'S CLAIMED SPECIFICITY. MATRIX EFFECTS FROM THE POOLED PLASMA SAMPLE USED IN THE SURVEY MAY HAVE CONTRIBUTED TO THE OBSERVED RESULT. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A FALSE-POSITIVE RESULT FOR ANTI-HCV G2 ELECSYS E2G 300 ON A COBAS E 801 ANALYTICAL UNIT DURING AN NRL SURVEY (SAMPLE E). THE SURVEY SAMPLE CONSISTED OF POOLED PLASMA FROM AUSTRALIAN AND WESTERN PACIFIC BLOOD DONORS. THE EXPECTED RESULT FOR THE SAMPLE WAS NON-REACTIVE. THE ELECSYS ANTI-HCV RESULT WAS REACTIVE WITH A VALUE OF 1.02 COI. ADDITIONAL TESTING OF THE SAME SAMPLE USING THE FUJIREBIO INNOLIA HCV SCORE YIELDED A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304451 ELECSYS ANTI-HCV II ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS MZO ROCHE DIAGNOSTICS 587906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown