BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV COMBI PT

    MDR report key: 23124521 · Received September 23, 2025

    Report

    Report Number
    1823260-2025-03460
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    April 28, 2021
    Report Date
    September 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    PMA / PMN Number
    BP160050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS E 602 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE ELECSYS HIV COMBI PT ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF CALIBRATION AND QUALITY CONTROL DATA CONFIRMED THAT ALL RESULTS WERE WITHIN EXPECTED RANGES. FURTHER ANALYSIS OF THE PATIENT SAMPLE INDICATED REACTIVITY TO ONE HIV-SPECIFIC ANTIGEN ONLY, WHICH STRONGLY SUGGESTS A FALSE REACTIVE RESULT. THE ROOT CAUSE WAS ATTRIBUTED TO A SAMPLE-SPECIFIC DISCREPANCY, AS FALSE REACTIVE RESULTS MAY OCCUR WITH THIS ASSAY.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A DISCREPANT REACTIVE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE HIV COMBI PT ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS 8000 CORE UNIT. THE PATIENT HAD A HISTORY OF REACTIVE RESULTS WITH THE HIV COMBI PT ASSAY, INCLUDING RESULTS OF 330.8 COI (REACTIVE) ON (B)(6) 2020, 314.5 COI (REACTIVE) ON (B)(6) 2020, AND 312 COI (REACTIVE) ON (B)(6) 2020. HIV VIRAL LOAD TESTING ON (B)(6) 2020 AND PROVIRAL DNA TESTING ON (B)(6) 2020 WERE NEGATIVE. SUBSEQUENT RESULTS INCLUDED 278 COI (REACTIVE) ON (B)(6) 2021, 253 COI (REACTIVE) ON (B)(6) 2021, AND 237 COI (REACTIVE) ON (B)(6) 2021 USING THE ELECSYS HIV DUO ASSAY. RAPID TESTS, INCLUDING ICT BIORAD AND ICT ALERE, CONSISTENTLY YIELDED NEGATIVE RESULTS FOR BOTH HIV-1 AND HIV-2 ANTIGENS AND ANTIBODIES. THE MOST RECENT SAMPLE TESTED WITH THE HIV COMBI PT ASSAY PRODUCED RESULTS OF 278.6 COI (REACTIVE) ON (B)(6) 2021 AND 253.9 COI (REACTIVE) ON (B)(6) 2021. THESE RESULTS WERE CONSISTENT WITH PRIOR REACTIVE FINDINGS FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196675 ELECSYS HIV COMBI PT HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 513552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown