BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST - 480T

    MDR report key: 12029167 · Received June 18, 2021

    Report

    Report Number
    2243471-2021-02029
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 18, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TOTAL OF 29 FALSE POSITIVE RESULTS WERE ALLEGED. THE EVALUATION OF THE DATA PROVIDED FOR THE AFFECTED RUNS, HOWEVER, SHOWS 10 POSITIVE RESULTS FROM ONE BATCH AND 24 POSITIVE RESULTS FROM THE OTHER BATCH. THE INVESTIGATION CARRIED OUT AND THE EVALUATION OF THE DATA PROVIDED DID NOT REVEAL ANY EVIDENCE OF A SYSTEM RELATED ISSUE ON EITHER OF THE TWO SYSTEMS. THE INVESTIGATION CARRIED OUT AND THE EVALUATION OF THE DATA PROVIDED INDICATES POSSIBLE PREANALYTICAL CONTAMINATION. THE DATA PROVIDED FROM SWAB TESTS ON THE INSTRUMENTS AND THE WORK AREA CONFIRMED THE CONTAMINATION OF THE CUSTOMER'S WORK AREA, WHICH HAS A HIGH PROBABILITY OF INADVERTENTLY CONTAMINATING OTHER SAMPLES. AFTER DECONTAMINATION OF THE SUSPECTED CONTAMINATED PROCESSING MODULES OF BOTH SYSTEMS AND THE CUSTOMER'S WORK AREA, NO FURTHER FALSE POSITIVE RESULTS WERE REPORTED BY THE CUSTOMER. THE INSTRUMENT MEETS THE MANUFACTURER'S OPERATING SPECIFICATIONS AND IS WORKING AS EXPECTED. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 8800 INSTRUMENT, PRODUCT CODE MZA CATALOG NUMBER 05412722001 AND UDI (B)(4). THE TEST USED ON THE COBAS 68/8800 SYSTEM IS THE KIT COBAS 6800/8800 SARS-COV-2 480T ASSAY PRODUCT CODE QJR, CATALOG NUMBER 09343733190 AND UDI (B)(4). THIS MDR IS SUBMITTED AGAINST THE KIT COBAS 6800/8800 SARS-COV-2 480T (PRODUCT CODE: QJR) INSTEAD OF THE THE COBAS 68/8800 SYSTEM, PER FDA REQUEST. ADDED IN B7 THAT NO RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. (B)(4).

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED AND IS ONGOING TO EVALUATE THE CUSTOMER ISSUE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 8800 INSTRUMENT, PRODUCT CODE MZA CATALOG NUMBER 05412722001 AND UDI (B)(4). THE TEST USED ON THE COBAS 68/8800 SYSTEM IS THE KIT COBAS 6800/8800 SARS-COV-2 480T ASSAY PRODUCT CODE QJR, CATALOG NUMBER 09343733190 AND UDI (B)(4). THIS MDR IS SUBMITTED AGAINST THE KIT COBAS 6800/8800 SARS-COV-2 480T (PRODUCT CODE: QJR) INSTEAD OF THE COBAS 68/8800 SYSTEM, PER FDA REQUEST. (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 THE UNITED STATES ALLEGED DISCREPANT RESULTS FOR 29 PATIENT SAMPLES WHILE USING THE COBAS® SARS-COV-2 TEST ON THE COBAS® 6/8800 SYSTEM. NO HARM WAS INDICATED. PER FDA GUIDANCE, 2 MDRS WILL BE FILED, ONE PER BATCH RUN THAT GENERATED THE ALLEGED RESULTS. THE CUSTOMER INITIALLY RAN A BATCH OF SAMPLES THAT GENERATED SARS-COV-2 POSITIVE RESULTS FOR 8 PATIENT SAMPLES. LATER THAT AFTERNOON, ANOTHER BATCH RUN GENERATED AN ADDITIONAL 21 POSITIVE SARS-COV-2 RESULTS. THE CUSTOMER QUESTIONED THE FINDINGS AND ORDERED A DECONTAMINATION OF THE INSTRUMENT. ALL SAMPLES WERE RETESTED AND CONFIRMED THE INITIAL FALSE POSITIVE RESULTS. AN INVESTIGATION HAS BEEN INITIATED AND IS ONGOING TO EVALUATE THE CUSTOMER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922909 COBAS SARS-COV-2 TEST - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. NA G34336

    Patients

    Seq Age Sex Outcome Treatment
    1