BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO

    MDR report key: 24052472 · Received January 13, 2026

    Report

    Report Number
    1823260-2026-00158
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    UDI-DI
    07613336166949
    PMA / PMN Number
    BP190403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS PRO SSU SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE PASSING AT THE TIME OF THE EVENT. PER PRODUCT LABELING, "ALL INITIALLY REACTIVE SAMPLES SHOULD BE REDETERMINED IN DUPLICATE WITH THE ELECSYS HIV DUO ASSAY. REPEATEDLY REACTIVE SAMPLES MUST BE CONFIRMED ACCORDING TO CDC RECOMMENDED CONFIRMATORY ALGORITHMS. THE SUBRESULTS FOR EITHER HIVAG OR AHIV CAN BE USED AS AN AID IN THE SELECTION OF THE CONFIRMATION ALGORITHM FOR REACTIVE SAMPLES." "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DETERMINED THAT THE ASSAY IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE POSITIVE ELECSYS HIV DUO RESULT FROM THE COBAS PRO SSU FOR ONE PATIENT. THE CUSTOMER TESTED THE SAMPLE IN TWO LABS, WITH THE E 801 AS WELL AS AN E 402 ANALYZER. THE RESULTS WERE REACTIVE. THE INITIAL RESULT WAS 122 COI (REACTIVE). THE SECOND RESULT WAS 122 COI (REACTIVE). THE THIRD RESULT WAS 123 COI (REACTIVE). THE FOURTH RESULT WAS 123 COI (REACTIVE). IT WAS NOT PROVIDED WHICH ANALYZER WAS USED FOR EACH RESULT. THE SAMPLE WAS SENT TO A PUBLIC HEALTH LAB, WHERE THE RESULT WAS NON-REACTIVE. THE CUSTOMER DEEMED THE NON-REACTIVE RESULT TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111734 ELECSYS HIV DUO HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 81244702 07613336166949

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown