BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 ¿ 480T

    MDR report key: 14281958 · Received May 4, 2022

    Report

    Report Number
    2243471-2022-00453
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 3, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF DATA INDICATED THAT AN INSTRUMENT CONTAMINATION EVENT OCCURRED DURING TESTING. AS IT WAS CONFIRMED THAT A WASH BUFFER BOTTLE WITH LIQUID WASTE WAS ACCIDENTALLY LOADED DIRECTLY INTO THE SYSTEM AND THIS CAUSED THE CONTAMINATION IN THE FLUIDIC LINES. THE ENGINEER WENT ON-SITE AND PERFORMED MULTIPLE REPLACEMENTS AND SEVERAL BLANK WATER RUNS. SINCE THEN NO FURTHER CONTAMINATION WAS FOUND. NO PRODUCT PROBLEM IDENTIFIED. 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: (B)(4); PRODUCT CODE: MZA). THE TEST USED ON THE COBAS SARS-COV-2 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).INITIAL REPORTER NAME AND ADDRESS: FACILITY NAME IS TRUNCATED DUE TO CHARACTER LIMIT. E1INITIAL REPORTER NAME AND ADDRESS: (B)(4)(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 WHEN TESTING WITH THE COBAS® SARS-COV-2 QUALITATIVE ASSAY FOR USE ON THE COBAS® 6800/8800 SYSTEMS. 6 SAMPLES WERE INITIALLY TESTED ON THE COBAS® 6800 RESULTING IN SARS-COV-2 POSITIVE. THE SAME SAMPLES WERE RETESTED ON THE COBAS® LIAT® AND THE GENEXPERT, RESULTING IN ALL NEGATIVE. THE RESULTS WERE INITIALLY REPORTED OUT AND LATER AMENDED AND REPORTED AS NEGATIVE. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. PER FDA¿S EUA GUIDANCE, 1 BATCH MDR WILL BE FILED TO REPRESENT ONE EVENT WITH A SINGLE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364414 COBAS® SARS-COV-2 ¿ 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA J01387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown