BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23135046 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03566
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    January 8, 2020
    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
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS MPX ASSAY PERFORMED WITHIN ITS INTENDED CLAIMS AND SPECIFICATIONS. A REVIEW OF THE DATA CONFIRMED THE REACTIVE PRIMARY POOL OF 6 (PP6) SAMPLE WITH A CYCLE THRESHOLD (CT) VALUE OF 38.6 AND LATE, MINIMAL AMPLIFICATION. THE RESOLUTION POOL OF 1 (RESP1) WAS NON-REACTIVE, WHILE THE REPEAT INDIVIDUAL DONOR TEST (IDT) WAS REACTIVE WITH A CT VALUE OF 38.8, ALSO SHOWING LATE, MINIMAL AMPLIFICATION. THESE FINDINGS SUGGEST THAT THE SAMPLE MAY HAVE BEEN AT OR NEAR THE ASSAY'S LIMIT OF DETECTION (LOD), WHICH CAN RESULT IN VARIABILITY IN REACTIVE AND NON-REACTIVE RESULTS. SEROLOGY RESULTS INDICATED NEGATIVE HEPATITIS B SURFACE ANTIGEN (HBSAG) AND POSITIVE HEPATITIS B CORE ANTIBODY (ANTI-HBC), CONSISTENT WITH A POTENTIAL OCCULT BLOOD INFECTION (OBI). HOWEVER, WITHOUT DONOR HISTORY, THIS COULD NOT BE CONFIRMED. NO ISSUES WERE IDENTIFIED IN THE BATCH TREND ANALYSIS, PRODUCT RELEASE, STABILITY REVIEW, OR INTERNAL NON-CONFORMANCE REVIEW. THE DONATION WAS REJECTED, AND NO HARM OR DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED AN UNEXPECTED NON-REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) USING THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER'S WORKFLOW INVOLVES TESTING SAMPLES IN A PRIMARY POOL OF 6 (PP6). IF A PP6 IS REACTIVE, RESOLUTION TESTING IS PERFORMED ON A POOL OF 1 (RESP1), AND THE RESP1 RESULT IS CONSIDERED FINAL. IN THIS CASE, THE PP6 WAS REACTIVE FOR HBV WITH A CYCLE THRESHOLD (CT) VALUE OF 38.6, AND THE GROWTH CURVE SHOWED LATE, MINIMAL AMPLIFICATION. RESOLUTION TESTING ON THE RESP1 WAS NON-REACTIVE. THE RESP1 SAMPLE WAS SUBSEQUENTLY REPEATED AS AN INDIVIDUAL DONOR TEST (IDT) FOR INCREASED CONFIDENCE, AND THE RESULT WAS REACTIVE WITH A CT VALUE OF 38.8. THE GROWTH CURVE FOR THE IDT ALSO SHOWED LATE, MINIMAL AMPLIFICATION. SEROLOGY TESTING FOR THE SAMPLE SHOWED NEGATIVE HEPATITIS B SURFACE ANTIGEN (HBSAG) AND POSITIVE HEPATITIS B CORE ANTIBODY (ANTI-HBC). THE DONOR HISTORY IS UNKNOWN. THE DONATION TYPE WAS BLOOD, AND THE DONATION WAS REJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385306 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG E29606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown