BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO

    MDR report key: 24177351 · Received January 26, 2026

    Report

    Report Number
    1823260-2026-00271
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    December 27, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    UDI-DI
    07613336166949
    PMA / PMN Number
    BP190403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE CALIBRATION RESULTS WERE IN THE EXPECTED RANGE. THE INVESTIGAITON DETERMINED THAT A SAMPLE-SPECIFIC DISCREPANCY CAUSED THE EVENT, AND FALSE REACTIVE RESULTS MAY OCCUR WITH THE ASSAY. PER PRODUCT LABELING, "THE SPECIFICITY OF ELECSYS HIV DUO IN INDIVIDUALS AT LOW RISK FOR HIV OR NEGATIVE FOR HIV IS 99.90% (6887/6894) WITH 95TH PERCENTILE CONFIDENCE LIMIT OF 99.79% TO 99.95%. THE SENSITIVITY OF ELECSYS HIV DUO IN INDIVIDUALS AT HIGH RISK FOR HIV WAS 100% (162/162) WITH A 95TH PERCENTILE CONFIDENCE LIMIT OF 97.68 % TO 100%." "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 SPECIFICATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HIV DUO RESULTS FROM THE COBAS E 402 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 1.25 COI (REACTIVE). THE FIRST REPEAT RESULT WAS 1.22 COI (REACTIVE). THE SECOND REPEAT RESULT ON (B)(6) 2025 WAS 1.25 COI (REACTIVE). THE CUSTOMER SUSPECTED THE RESULTS TO BE FALSE POSITIVES. THE CHEMILUMINESCENT IMMUNOASSAY (CLIA) RESULT FROM AN OUTSOURCED LABORATORY WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240632 ELECSYS HIV DUO HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 83909202 07613336166949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male