BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO

    MDR report key: 23135276 · Received September 24, 2025

    Report

    Report Number
    1823260-2025-03580
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    February 5, 2025
    Report Date
    September 24, 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 MODULE (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE ELECSYS HIV DUO ASSAY PERFORMED WITHIN SPECIFICATIONS, AND A PRODUCT PROBLEM WAS NOT IDENTIFIED. A REVIEW OF CALIBRATION AND QUALITY CONTROL DATA CONFIRMED ALL RESULTS WERE WITHIN EXPECTED RANGES. TESTING OF ONE SAMPLE AT THE MANUFACTURER'S FACILITY ON 02-APR-2025, USING THE ELECSYS HIV DUO ASSAY GENERATED A REACTIVE RESULT WITH SUBRESULTS OF HIVAG 73.3 COI AND AHIV 0.053 COI. THIS CONFIRMED A FALSE REACTIVE RESULT IN THE HIVAG MODULE. FURTHER TESTING WITH A PROTOTYPE ASSAY IN DEVELOPMENT PRODUCED NON-REACTIVE RESULTS FOR BOTH HIVAG AND AHIV. ANALYSIS EXCLUDED INTERFERENCE FROM THE PATIENT'S JAK INHIBITOR MEDICATION AS THE CAUSE OF THE OBSERVED REACTIVITY. IT WAS NOTED THAT AUTOIMMUNE CONDITIONS, SUCH AS SEVERE ECZEMA, MAY INCREASE THE LIKELIHOOD OF ASSAY INTERFERENCE. THE INVESTIGATION CONCLUDED THAT THE OBSERVED REACTIVITY WAS NOT RELATED TO A PRODUCT ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED FALSE REACTIVE RESULTS WITH THE HIV DUO ELECSYS E2G 300 V2 ASSAY ON THE COBAS E 801 MODULE FOR ONE PATIENT SAMPLE. ON (B)(6) 2025, THE FIRST SAMPLE (ID (B)(6)) WAS TESTED USING THE ELECSYS HIV DUO ASSAY AND GENERATED A REACTIVE RESULT WITH SUBRESULTS OF HIVAG 102 COI AND AHIV 0.063 COI. FOLLOW-UP TESTING OF THE SAME SAMPLE USING ABBOTT ALINITY HIV, LIAISON DIASORIN HIV, GENESCREEN, AND MP DIAGNOSTICS WESTERN BLOT ASSAYS ALL PRODUCED NEGATIVE RESULTS. A SECOND SAMPLE (ID (B)(6)) WAS COLLECTED AND TESTED USING THE ELECSYS HIV DUO ASSAY, WHICH AGAIN GENERATED A REACTIVE RESULT WITH SUBRESULTS OF HIVAG 99.2 COI AND AHIV 0.060 COI. ALL FOLLOW-UP ASSAYS FOR THIS SAMPLE, INCLUDING ABBOTT ALINITY HIV, LIAISON DIASORIN HIV, GENESCREEN, AND MP DIAGNOSTICS WESTERN BLOT, PRODUCED NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394832 ELECSYS HIV DUO HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 789953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown