BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 18779258 · Received February 26, 2024

    Report

    Report Number
    2243471-2024-00545
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 31, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DATA CONFIRMED THAT ALL RUNS GENERATED VALID RESULTS. THE RESULTS WERE TYPICAL OF SAMPLES AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. THE SYSTEM DATA SHOWED NO ANOMALIES REGARDING SAMPLES OR REAGENT PIPETTING. THE SYSTEM IS WORKING AS EXPECTED. A CLEAR ROOT CAUSE COULD NOT BE ESTABLISHED. IT COULD BE OBSERVED THAT THERE WAS LIKELY LOW-LEVEL CONTAMINATION AS THE ISSUE DECREASED AFTER THE DECONTAMINATION PROCEDURE AND EXCHANGE OF ALL REAGENTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL THE SAMPLES ON A GIVEN RUN. THIS WILL REPRESENT ONE EVENT ON A SINGLE DEVICE AS PER FDA GUIDANCE. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 6800 SYSTEM (PRODUCT CATALOG NUMBER 05524245001; UDI: (B)(4); PMA 510K: BK140196; PRODUCT CODE: MZA). THE TEST USED ON THE COBAS 6800 SYSTEM IS THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA200009, PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST (480T) IS 09343733190 AND THE UDI IS (B)(4).

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER ALLEGED DISCREPANT RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES WHILE USING THE COBAS® SARS-COV-2 NUCLEIC ACID TEST ON THE COBAS® 68/8800 SYSTEMS. IT WAS REPORTED THAT SAMPLES ON A SINGLE RUN GENERATED A POSITIVE RESULT FOR SARS-COV-2. THE SAME SAMPLES WERE RETESTED ON A DIFFERENT PLATFORM (CEPHEID) WHICH YIELDED A NEGATIVE RESULT FOR SARS-COV-2. THE INITIAL POSITIVE RESULTS WERE RELEASED AND THEN AMENDED. NO HARM WAS ALLEGED. AN INVESTIGATION IS BEING CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 1 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909644 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K10700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown