BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO

    MDR report key: 23155341 · Received September 26, 2025

    Report

    Report Number
    1823260-2025-03767
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    February 19, 2021
    Report Date
    September 26, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    PMA / PMN Number
    BP190403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS E 801 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE ELECSYS HIV DUO ASSAY REAGENT PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF QUALITY CONTROL DATA CONFIRMED THAT ALL RESULTS WERE WITHIN EXPECTED RANGES. INSTRUMENT ALARM TRACES DID NOT INDICATE ANY ISSUES RELATED TO THE REPORTED EVENT. TESTING OF THE PATIENT SAMPLE REVEALED REACTIVITY WITH MONOCLONAL ANTIBODIES USED IN THE HIVAG DETECTION MODULE OF THE ELECSYS HIV DUO ASSAY. CONFIRMATORY TESTING WITH THE ELECSYS HIV AG CONFIRMATORY TEST DETERMINED THE RESULT TO BE FALSE REACTIVE. THE INVESTIGATION WAS LIMITED BY THE RECEIPT OF A THAWED PATIENT SAMPLE WITH LOW VOLUME, WHICH REQUIRED DILUTION FOR FURTHER TESTING. THE ROOT CAUSE WAS ATTRIBUTED TO A FALSE REACTIVE RESULT, WHICH IS A KNOWN LIMITATION OF THE ASSAY AS DESCRIBED IN THE PRODUCT'S METHOD SHEET. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT REACTIVE RESULTS FOR ONE PATIENT SAMPLE TESTED IN DUPLICATE USING THE HIV DUO ELECSYS E2G 300 ASSAY ON THE COBAS E 801 MODULE. THE INITIAL RESULTS FROM (B)(6) 2021 WERE 40.5 COI, 40.9 COI, AND 41.3 COI, ALL OF WHICH WERE REACTIVE. ADDITIONAL RESULTS FROM (B)(6) 2021 WERE 43.6 COI, 33.9 COI, AND 34.2 COI, ALL OF WHICH WERE ALSO REACTIVE. FURTHER TESTING OF THE SAME SAMPLE USING OTHER HIV ASSAYS, INCLUDING THE HIV 1/2 AG-AB CLIA LIAISON XL, HIV 1/2 WESTERN BLOT MP DIAGNOSTICS, AND HIV 1/2 AG-AB EIA BIORAD GENSCREEN ULTRA, YIELDED NON-REACTIVE OR NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059222 ELECSYS HIV DUO HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 483078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown