BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO

    MDR report key: 23830256 · Received December 17, 2025

    Report

    Report Number
    1823260-2025-05182
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 17, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    PMA / PMN Number
    BP190403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE EVENT WAS CONSISTENT WITH A SAMPLE-SPECIFIC DISCREPANCY AS PER PRODUCT LABELING FOR THE ASSAY, SINGLE FALSE REACTIVE RESULTS MAY OCCUR, AND THE ELECSYS HIV DUO ASSAY SPECIFICITY IS < 100%. THE ELECSYS HIV DUO ASSAY PERFORMED WITHIN SPECIFICATION. THERE WAS NO EVIDENCE OF A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE REAGENT EXPIRATION DATES WERE NOT PROVIDED. THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FOR ONE PATIENT FROM THE COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 RESULTS WERE 2189, 2355, AND 2296 (AFTER ULTRACENTRIFUGATION) USING REAGENT LOT 839092. THESE RESULTS WERE CONSIDERED POSITIVE. ON (B)(6) 2025, SAMPLE 2 RESULT WAS 2083 USING REAGENT LOT 852715. THIS RESULT WAS CONSIDERED POSITIVE. BOTH SAMPLES WERE SENT FOR WESTERN BLOT, AND THE RESULTS WERE NEGATIVE. BOTH SAMPLES WERE SENT TO ANOTHER LAB FOR TESTING WITH AG P24. THE RESULTS WERE NEGATIVE ON AG/AB COMBO ALINITY ABBOTT. USING IMMUNOFLUORIMÉTRIE MULTIPLEX BIOPLEX 2220, THE AG P24 WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186484 ELECSYS HIV DUO HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 839092, 852715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female