BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23089115 · Received September 18, 2025

    Report

    Report Number
    2243471-2025-03151
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    March 4, 2023
    Report Date
    September 18, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 5800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE RAW DATA CONFIRMED HBV REACTIVE RESULTS FOR TWO SAMPLES, WITH STRONG AMPLIFICATION AND LATE CT VALUES OBSERVED. NO ABNORMALITIES WERE IDENTIFIED, AND THE RESULTS APPEARED TO BE CONSISTENT WITH LOW-LEVEL HBV DETECTION. HOWEVER, THE MOST LIKELY CAUSE OF THE REPORTED DISCREPANCY WAS ATTRIBUTED TO PRE-ANALYTICAL CONTAMINATION. NO PRODUCT ISSUE WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED TWO FALSE REACTIVE RESULTS FOR HEPATITIS B VIRUS (HBV) USING THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY ON THE COBAS 5800 INSTRUMENT. THE CUSTOMER REPORTED THAT A BATCH OF 33 SAMPLES WAS TESTED, AND TWO SAMPLES GENERATED HBV REACTIVE RESULTS. NEW SAMPLES WERE TAKEN FROM THE ORIGINAL BLOOD BAGS AND RE-TESTED, YIELDING NON-REACTIVE RESULTS. BOTH SAMPLES WERE INDIVIDUAL DONOR TESTING (IDT) PLASMA COLLECTED IN EDTA TUBES. THE CUSTOMER CENTRIFUGED THE SAMPLES AT 4500 G FOR 20 MINUTES. THE SAMPLES WERE ALSO TESTED ON AN UNSPECIFIED IMMUNOASSAY, WHICH PRODUCED NEGATIVE RESULTS. THE SAMPLES WERE ULTIMATELY RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827140 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG H33238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown