BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 24570023 · Received March 11, 2026

    Report

    Report Number
    2243471-2026-00856
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). AN ANALYSIS OF THE PCR GROWTH CURVES OF THE POOL AND IDT VERIFIED ACCURATE CALLS. THERE IS NO INDICATION OF A MISCALLING BASED ON THE GENERATED PCR SIGNALS OF THE HBV DETECTION CHANNEL. THE DATA ANALYSIS REVEALED NO ANOMALIES IN THE ALGORITHM THAT COULD LEAD TO ERRONEOUS OUTCOMES. FURTHERMORE, THE INTERNAL CONTROL (IC) IN BOTH THESE EXHIBITED A ROBUST AMPLIFICATION CURVE, WHICH INDICATES THE ABSENCE OF POTENTIAL PCR INHIBITORS IN THE SAMPLE MATRIX. OVERALL, THE PROVIDED DATA DID NOT REVEAL OR INDICATE ANY HARDWARE ISSUE OR A PRODUCT ISSUE WITH THE COBAS® MPX ASSAY N02151, WHICH WAS USED WHEN THE QUESTIONED NON-REACTIVE RESULT WAS OBTAINED. THIS IS FURTHER SUPPORTED BY THE VALID NEGATIVE CONTROL. THE POSITIVE AND NEGATIVE CONTROLS EXHIBITED ROBUST AMPLIFICATION CURVES FOR THE INTERNAL CONTROL (IC), AND THE TARGETS (HIV-1M, HIV-1O, HIV-2, HBV AND HCV), INDICATING THE PROPER FUNCTIONING OF PCR AND SAMPLE PREPARATION PROCESSES. THE ROOT CAUSE IS MOST LIKELY DUE TO THE DILUTION EFFECT INHERENT IN POOLED TESTING, COMBINED WITH THE POISSON DISTRIBUTION AT LOW VIRAL LOADS. IN A PP6 FORMAT, THE INDIVIDUAL SAMPLE IS DILUTED BY A FACTOR OF 6; WHEN A SAMPLE HAS A LOW VIRAL TITER (AS EVIDENCED BY THE UNDILUTED IDT), THIS 1:6 DILUTION CAN PUSH THE TARGET CONCENTRATION BELOW THE STATISTICAL THRESHOLD FOR DETECTION. FURTHERMORE, AT THESE LOW CONCENTRATIONS, VIRAL PARTICLES MAY NOT BE UNIFORMLY DISTRIBUTED (THE POISSON EFFECT), MEANING A SPECIFIC ALIQUOT TAKEN FOR A POOL MAY LACK SUFFICIENT TARGET MATERIAL FOR A REACTIVE RESULT COMPARED TO THE UNDILUTED IDT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® MPX - 480T ASSAY FOR A DONOR SAMPLE TESTED ON A COBAS 6800 INSTRUMENT. THE INITIAL RESULT OF A PRIMARY POOL OF 6 (PP6) WAS NON-REACTIVE. THE SEROLOGY RESULT WAS POSITIVE FOR HBV (2500). THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE REPEAT RESULT AS AN INDIVIDUAL DONOR TESTING (IDT) WAS REACTIVE FOR HBV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628964 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG N02151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown