BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HCV II

    MDR report key: 23095207 · Received September 19, 2025

    Report

    Report Number
    1823260-2025-03079
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    June 20, 2020
    Report Date
    September 19, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZO
    PMA / PMN Number
    P140021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS E 601 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE ELECSYS ANTI-HCV II ASSAY PERFORMED WITHIN SPECIFICATIONS. THE CALIBRATION AND QUALITY CONTROL DATA WERE REVIEWED AND FOUND TO BE WITHIN THE EXPECTED RANGES. ALARM TRACES INDICATED ABNORMAL SAMPLE ASPIRATION EVENTS, BUT THESE WERE NOT DEEMED TO HAVE IMPACTED THE RESULTS. THE NEGATIVE RESULT OBTAINED WITH THE ELECSYS ANTI-HCV II ASSAY WAS CONFIRMED BY IMMUNOBLOT TESTING USING THE INNO-LIA HCV SCORE ASSAY. THE POSITIVE RESULTS OBTAINED WITH THE DIASORIN AND ABBOTT SYSTEMS WERE ASSESSED AS MOST LIKELY FALSE POSITIVES. NO SAMPLE MATERIAL WAS PROVIDED FOR FURTHER INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A POSSIBLE FALSE NEGATIVE RESULT FOR THE ELECSYS ANTI-HCV II ASSAY ON THE COBAS E 601 MODULE FOR ONE PATIENT SAMPLE. ON (B)(6) 2020, THE SAMPLE WAS TESTED ON THE COBAS E 601 MODULE AND GENERATED A NON-REACTIVE RESULT OF 0.045 COI. ON (B)(6) 2020, THE SAME SAMPLE WAS TESTED ON THE DIASORIN LIAISON AND ABBOTT SYSTEMS, YIELDING REACTIVE RESULTS OF 1.2 COI AND 4.26 COI, RESPECTIVELY. ON (B)(6) 2020, A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED ON THE COBAS E 601 MODULE AND GENERATED A NON-REACTIVE RESULT OF 0.042 COI. ON (B)(6) 2020, THE NEW SAMPLE WAS TESTED ON THE DIASORIN LIAISON, YIELDING A REACTIVE RESULT OF 2.2 COI, AND ON THE COBAS E 801 MODULE AT ANOTHER LABORATORY, YIELDING A NON-REACTIVE RESULT OF 0.0533 COI. ON (B)(6) 2020, CONFIRMATORY TESTING USING THE INNO-LIA HCV SCORE IMMUNOBLOT ASSAY FROM FUJIREBIO EUROPE PRODUCED A NEGATIVE RESULT. THE DISCREPANT NON-REACTIVE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760736 ELECSYS ANTI-HCV II ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS MZO ROCHE DIAGNOSTICS 44585401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown