BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV COMBI PT

    MDR report key: 23137142 · Received September 24, 2025

    Report

    Report Number
    1823260-2025-03628
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    May 14, 2021
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZF
    PMA / PMN Number
    BP160050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS E 601 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, EXCEPT FOR CALIBRATOR 2 SIGNALS, WERE WITHIN EXPECTED RANGES. THE LOWER SIGNALS OBSERVED FOR CALIBRATOR 2 DID NOT IMPACT THE OVERALL ASSAY PERFORMANCE. THE INVESTIGATION WAS LIMITED AS PATIENT SAMPLE MATERIAL FROM 23-FEB-2021 WAS NOT AVAILABLE FOR FURTHER ANALYSIS. ADDITIONALLY, THE ELECSYS HIV COMBI PT ASSAY IS NOT VALIDATED FOR USE IN PATIENTS UNDERGOING ANTIRETROVIRAL THERAPY, WHICH MAY SUPPRESS VIRAL ANTIGEN PRODUCTION AND AFFECT ASSAY SENSITIVITY. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A DISCREPANT NON-REACTIVE RESULT (0.204 COI) FOR A PATIENT SAMPLE TESTED WITH THE HIV COMBI PT ELECSYS COBAS E 100 ASSAY ON A COBAS 6000 CORE UNIT 150 (JP VERSION). THE PATIENT, WHO IS HIV POSITIVE AND HAS BEEN ON ANTIRETROVIRAL THERAPY FOR TWO YEARS, WAS TESTED ON (B)(6) 2021, AND THE NON-REACTIVE RESULT WAS REPORTED OUT OF THE LABORATORY AS THE PATIENT'S MEDICAL HISTORY WAS NOT KNOWN AT THE TIME. THE PATIENT RETURNED ON (B)(6) 2021 AND WAS TESTED REACTIVE FOR HIV USING A DIFFERENT SAMPLE. NO NUMERIC RESULT OR INFORMATION REGARDING THE HIV METHOD OR ASSAY USED ON (B)(6) 2021 WAS PROVIDED. THE SPECIMEN FROM (B)(6) 2021 WAS SENT TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) FOR CONFIRMATION, BUT NO RESULTS HAVE BEEN RECEIVED TO DATE. NO ADDITIONAL HIV ASSAY RESULTS, HIV PCR RNA, OR WESTERN BLOT RESULTS WERE PROVIDED, AND NO RE-TESTING OF THE (B)(6) 2021 SAMPLE USING THE HIV COMBI PT ASSAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394950 ELECSYS HIV COMBI PT HIV DETECTION TEST MZF ROCHE DIAGNOSTICS 478856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown