BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST

    MDR report key: 23137713 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03634
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    December 8, 2021
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 8800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 6800/8800 MPX 480T US-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. INTERNAL CONTROL AMPLIFICATION WAS ROBUST FOR BOTH THE POOLED AND INDIVIDUAL TESTING (IDT) SAMPLES, WITH NO EVIDENCE OF PCR SUPPRESSION. THE HBV AMPLIFICATION OBSERVED IN THE IDT SAMPLE WAS VERY WEAK, WITH A LATE CYCLE THRESHOLD (CT) VALUE OF 40.3, MAKING IT DIFFICULT TO DISTINGUISH BETWEEN TRUE TARGET AMPLIFICATION AND NON-SPECIFIC AMPLIFICATION. NON-SPECIFIC AMPLIFICATION FOR HBV WITH THE MPX TEST IS UNCOMMON BUT POSSIBLE. IF TRUE TARGET AMPLIFICATION OCCURRED, IT COULD BE ATTRIBUTED TO CROSS-CONTAMINATION OR AN OCCULT HBV INFECTION; HOWEVER, CROSS-CONTAMINATION IS CONSIDERED LESS LIKELY DUE TO THE ABSENCE OF OTHER HBV-REACTIVE SAMPLES IN THE DATASET. THE ABSENCE OF A/D PLATES LIMITED FURTHER INVESTIGATION INTO THE NATURE OF THE REACTIVE RESULT. NO HCV AMPLIFICATION WAS OBSERVED IN EITHER THE POOLED OR IDT SAMPLES. THE DISCREPANCY IN HCV RESULTS MAY BE ATTRIBUTED TO A RESOLVED PREVIOUS HCV INFECTION, AS HCV RNA CAN BECOME UNDETECTABLE FOLLOWING SPONTANEOUS RESOLUTION OR TREATMENT, WHILE HCV ANTIBODIES REMAIN DETECTABLE THROUGH SEROLOGY TESTING. NO SYSTEMIC REAGENT ISSUES OR PRODUCT PROBLEMS RELATED TO THE CUSTOMER COMPLAINT WERE IDENTIFIED. 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 DISCREPANT RESULTS WITH THE KIT COBAS 6800/8800 MPX 480T US-IVD ON THE COBAS 8800 INSTRUMENT. THE SAMPLE IN QUESTION WAS INITIALLY INCLUDED IN A POOL THAT GENERATED A NON-REACTIVE RESULT ON (B)(6) 2021. ON (B)(6) 2021, THE SAME SAMPLE WAS TESTED INDIVIDUALLY (IDT) AND WAS REACTIVE FOR HEPATITIS B VIRUS (HBV) WITH A CYCLE THRESHOLD (CT) VALUE OF 40.3, WHILE RESULTS FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND HEPATITIS C VIRUS (HCV) WERE NON-REACTIVE. SEROLOGY TESTING FOR HBV INCLUDED ABBOTT ALINITY ANTI-HBC, WHICH WAS NON-REACTIVE AT 0.50 SIGNAL-TO-CUTOFF (S/CO), AND ABBOTT ALINITY HBSAG, WHICH WAS NON-REACTIVE AT 0.26 S/CO. SEROLOGY TESTING FOR HCV WAS POSITIVE, WITH ABBOTT ALINITY ANTI-HCV RESULTS OF 2.43 S/CO, 2.85 S/CO, AND 2.79 S/CO, AND ORTHO HCV VER 3.0 ANTI-HCV RESULTS OF 5.235 S/CO, 5.946 S/CO, AND 6.442 S/CO. ALL RESULTS WERE RELEASED, AND THE DONATION WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614309 COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG G15726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown