BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23155363 · Received September 26, 2025

    Report

    Report Number
    2243471-2025-03757
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 4, 2024
    Report Date
    September 26, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS® MPX ASSAY PERFORMED WITHIN SPECIFICATIONS. DATA ANALYSIS INDICATED THAT THE HIV TARGET FOR THE SAMPLE ON (B)(6) 2024 SHOWED LATE AMPLIFICATION WITH A CYCLE THRESHOLD (CT) VALUE OF 37.04, WHICH IS CONSISTENT WITH A SAMPLE AT THE LIMIT OF DETECTION (LOD). POSITIVE CONTROL TARGETS FOR HIV WERE ROBUST AND SIGMOIDAL, CONFIRMING PROPER ASSAY PERFORMANCE. A REVIEW OF COMPLAINT HISTORY REVEALED NO PRIOR ALLEGATIONS OF RESULT DISCREPANCIES FOR MPX LOT K21369. THE MOST LIKELY CAUSE FOR THE DISCREPANT HIV RESULT WAS ATTRIBUTED TO THE SAMPLE HAVING A VIRAL TITER AT THE LIMIT OF DETECTION OF THE ASSAY. SUCH SAMPLES MAY YIELD RESULTS THAT WAVER BETWEEN REACTIVE AND NON-REACTIVE, WHICH IS AN EXPECTED BEHAVIOR FOR LOD SAMPLES.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED AN UNEXPECTED NON-REACTIVE RESULT FOR HIV WHEN USING THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER REPORTED THAT AN EXTERNAL CONTROL WAS NON-REACTIVE FOR HIV ON (B)(6) 2024 AND REACTIVE FOR HIV ON (B)(6) 2024. THE EXPECTED RESULT FOR THE EXTERNAL CONTROL WAS POSITIVE. DATA PROVIDED BY THE CUSTOMER INDICATED THAT THE SAMPLE WITH THE SUFFIX '-D' WAS NON-REACTIVE FOR HIV ON (B)(6) 2024 AND REACTIVE FOR HIV ON (B)(6) 2024. THE HIV TARGET FOR THE SAMPLE ON (B)(6) 2024 SHOWED LATE AMPLIFICATION WITH A CYCLE THRESHOLD (CT) VALUE OF 37.04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244748 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K21369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown