BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 QUALITATIVE 480T

    MDR report key: 15928757 · Received December 6, 2022

    Report

    Report Number
    2243471-2022-01018
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 10, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QQX
    PMA / PMN Number
    K213804
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE COULD NOT BE ESTABLISHED. HOWEVER, THE REASON FOR THE DISCREPANCIES OBSERVED BY THE CUSTOMER IS LIKELY SAMPLE-SPECIFIC. THE DATA DOES NOT SHOW ANY INDICATION OF A PRODUCT PROBLEM OR SYSTEMIC ISSUE. THE DIFFERENCES IN TECHNOLOGY BETWEEN THE ROCHE PRODUCT AND THE NON-ROCHE PRODUCT ALSO SHOULD BE TAKEN INTO ACCOUNT AND CANNOT BE RULED OUT. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS SARS-COV-2 QUALITATIVE TEST FOR USE ON THE COBAS 5800/6800/8800 SYSTEMS CE-IVD, CATALOG NUMBER 09448870190 AND UDI (B)(4) WHICH IS NOT YET AVAILABLE IN THE US. THE SIMILAR ASSAY CURRENTLY AVAILABLE IN THE US UNDER EMERGENCY USE AUTHORIZATION IS THE COBAS SARS-COV-2 TEST FOR USE ON THE COBAS 6800-8800 SYSTEM (B)(4), 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 FROM IRELAND ALLEGED DISCREPANT RESULTS FOR A SINGLE PATIENT WHILE USING THE COBAS SARS-COV-2 NUCLEIC ACID TEST ON THE COBAS 58/68/8800 SYSTEMS. THE ALLEGED SAMPLE INITIALLY GENERATED POSITIVE RESULTS FOR TARGET 1 (SARS-COV-2) AND TARGET 2 (PAN-SARBECOVIRUS). THE SAME SAMPLE WAS REPEATED ON ANOTHER PLATFORM (TAQPATH COVID-19 CE-IVD ASSAY) GENERATING SARS-COV-2 NEGATIVE RESULT. THE SAMPLE WAS REPEATED ONCE AGAIN ON THE SAME COBAS 6800 GENERATING NEGATIVE RESULTS FOR BOTH TARGETS. THE RESULTS WERE RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION WAS 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
    2542184 COBAS® SARS-COV-2 QUALITATIVE 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QQX ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H33956

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown