BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO

    MDR report key: 23168724 · Received September 29, 2025

    Report

    Report Number
    1823260-2025-03938
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    May 9, 2023
    Report Date
    September 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    PMA / PMN Number
    BP190403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF QUALITY CONTROL DATA CONFIRMED THAT ALL POSITIVE AND NEGATIVE CONTROL RECOVERIES WERE WITHIN THE SPECIFIED RANGES. HOWEVER, A PATTERN OBSERVED IN ONE CONTROL LEVEL SUGGESTED A POTENTIAL HANDLING ISSUE. THE ROOT CAUSE OF THE DISCREPANT RESULTS COULD NOT BE DEFINITIVELY DETERMINED. CONTAMINATION OF THE CPD PLASMA BAG MATERIAL OR A SAMPLE MIX-UP AT THE BLOOD DONATION SITE WAS CONSIDERED A PLAUSIBLE EXPLANATION. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT ELECSYS HIV DUO RESULTS BETWEEN A SERUM SAMPLE AND A CPD PLASMA BAG FOR ONE PATIENT TESTED ON A COBAS E 801 MODULE. ON (B)(6) 2023, THE SERUM SAMPLE WAS TESTED USING THE ELECSYS HIV DUO ASSAY AND GENERATED A RESULT OF 0.195 COI (NEGATIVE). TESTING OF THE SAME SAMPLE ON THE ABBOTT ALINITY HIV ASSAY PRODUCED A RESULT OF 0.08 S/CO (NEGATIVE). BOTH RESULTS WERE CONCORDANTLY NEGATIVE. THE CPD PLASMA SAMPLE FROM THE SAME BLOOD DONOR WAS TESTED USING THE ELECSYS HIV DUO ASSAY AND GENERATED A RESULT OF 10.1 COI (POSITIVE), WITH HIVAG 0.193 COI AND AHIV 10.1 COI. A REPEAT TEST ON THE SAME ASSAY PRODUCED A RESULT OF 11.1 COI (POSITIVE), WITH HIVAG 0.183 COI AND AHIV 11.1 COI. ADDITIONAL TESTING OF THE CPD PLASMA SAMPLE INCLUDED THE ELECSYS HIV COMBI PT ASSAY, WHICH GENERATED A RESULT OF 14.56 COI (POSITIVE); THE ABBOTT ALINITY HIV ASSAY, WHICH GENERATED A RESULT OF 2.44 S/CO (POSITIVE); THE ABBOTT ARCHITECT HIV ASSAY, WHICH GENERATED A RESULT OF 2.78 S/CO (POSITIVE); THE HIV AB VIDAS TEST, WHICH GENERATED A RESULT OF 0.69 (POSITIVE); AND AN HIV AB ELISA TEST, WHICH WAS ALSO POSITIVE. POLYMERASE CHAIN REACTION (PCR) TESTING USING THE HIV 1/2 GENIUS DEVICE CONFIRMED THE ABSENCE OF HIV ANTIGEN. ALL MEASUREMENTS FOR ANTI-HIV ANTIBODIES WERE CONCORDANTLY REACTIVE. ON (B)(6) 2023, AN EDTA PLASMA SAMPLE FROM THE SAME DONOR WAS TESTED USING THE ELECSYS HIV DUO ASSAY AND GENERATED A NEGATIVE RESULT. TESTING OF THE SAME SAMPLE ON THE ABBOTT ALINITY HIV ASSAY ALSO PRODUCED A NEGATIVE RESULT. BOTH RESULTS WERE CONCORDANTLY NEGATIVE. SUBSEQUENT TESTING OF A NEW CPD PLASMA SAMPLE, AS WELL AS FRESH FROZEN PLASMA (FFP) AND PLASMA FROM THREE OTHER BLOOD DONORS, PRODUCED NEGATIVE RESULTS ON THE ELECSYS HIV DUO ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304395 ELECSYS HIV DUO HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 631252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown