BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HCV II

    MDR report key: 23111306 · Received September 22, 2025

    Report

    Report Number
    1823260-2025-03370
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    November 11, 2024
    Report Date
    September 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZO
    PMA / PMN Number
    K221693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS PURE E 402 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(6). THE INVESTIGATION DETERMINED THAT THE ELECSYS ANTI-HCV II ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF CALIBRATION AND QUALITY CONTROL DATA INDICATED THAT THE CALIBRATION WAS PERFORMED SUCCESSFULLY ON 26-OCT-2024 USING KIT LOT 791721. HOWEVER, QUALITY CONTROL DATA FOR THE DAY OF THE EVENT WAS NOT AVAILABLE, AND IT WAS NOTED THAT THE CUSTOMER DID NOT CONSISTENTLY USE BOTH LEVELS OF QUALITY CONTROL MATERIALS AS RECOMMENDED. ADDITIONALLY, SEVERAL ALARMS WERE RECORDED ON (B)(6) 2024, WHICH MAY HAVE IMPACTED THE SYSTEM'S PERFORMANCE. THE ROOT CAUSE OF THE FALSE NON-REACTIVE RESULT COULD NOT BE DETERMINED, BUT IT WAS NOTED THAT FALSE RESULTS MAY OCCUR AS THE SENSITIVITY OF THE ASSAY IS LESS THAN 100%. THE REACTIVE RESULT FOR THE PATIENT SAMPLE WAS CONFIRMED BY POLYMERASE CHAIN REACTION (PCR) TESTING. THE USE OF BOTH LEVELS OF QUALITY CONTROL MATERIALS IS HIGHLY RECOMMENDED TO ENSURE RELIABLE ASSAY PERFORMANCE. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A FALSE NON-REACTIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ANTI-HCV G2 ELECSYS E2G 300 V2 ASSAY ON THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULTS OBTAINED ON (B)(6) 2024 AND (B)(6) 2024 WERE 0.152 COI, 0.167 COI, AND 0.154 COI, ALL OF WHICH WERE NON-REACTIVE. A SUBSEQUENT RESULT FROM THE SAME SAMPLE WAS REPORTED AS NON-REACTIVE AT 0.49 S/CO USING ELECTROCHEMILUMINESCENCE IMMUNOASSAY (ECLIA), THOUGH THIS RESULT FORMAT DIFFERED FROM THE INITIAL RESULTS. FURTHER TESTING INCLUDED AN ANTI-HCV ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA), WHICH WAS REACTIVE, AND A HEPATITIS C VIRUS QUANTITATIVE POLYMERASE CHAIN REACTION (PCR) TEST, WHICH WAS REACTIVE WITH A VIRAL LOAD OF 922.70 IU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595438 ELECSYS ANTI-HCV II HEPATITIS C ANTIBODY ASSAY MZO ROCHE DIAGNOSTICS 791721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown