BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS 6800-8800 SYSTEM

    MDR report key: 11926386 · Received June 2, 2021

    Report

    Report Number
    2243471-2021-01599
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA202635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 6800 SYSTEM. THE TEST USED ON THE COBAS 6800 SYSTEM IS THE COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA(B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST IS 09233474190 AND THE UDI IS (B)(4). CORRECTED SECTION D AND SECTION G (MANUFACTURING SITE DETAILS) BASED ON FEEDBACK RECEIVED FROM FDA ON 17-JUN-2021 ((B)(6)).

    Additional Manufacturer Narrative · 0

    THROUGH THE COURSE OF THE INVESTIGATION, WHICH INCLUDED A REVIEW OF THE INSTRUMENT'S PERFORMANCE AND QC KIT RELEASE RECORDS FOR THE KIT LOT (G23399) USED, NO ISSUES WERE IDENTIFIED. DURING LOCAL TROUBLESHOOTING, ONSITE STUDIES WERE PERFORMED TO TRY TO RECREATE THE CUSTOMER'S SITUATION, AND NO FALSE POSITIVE RESULTS COULD BE REPRODUCED. ALSO ALL OTHER INSTRUMENT CHECKS DID NOT REVEAL ANY OTHER PROBLEMS. PREANALYTICAL HANDLING ISSUES WERE IDENTIFIED AND COMMUNICATED TO THE CUSTOMER. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 6800 SYSTEM. THE TEST USED ON THE COBAS 6800 SYSTEM IS THE COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS 6800-8800 SYSTEM ((B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST IS 09233474190 AND THE UDI IS (B)(4). (B)(4)

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) REPORTED AN UNEXPECTED NUMBER OF POSITIVE RESULTS WITH THE COBAS SARS-COV-2 TEST FOR A SPECIFIC RUN PERFORMED ON (B)(6) 2021. DURING THIS RUN, THERE WERE 21 SAMPLES THAT GENERATED POSITIVE RESULTS IN EITHER TARGET 1 (SARS-COV-2) AND/OR TARGET 2 (SARBECOVIRUS) WITH LATE CT VALUES. WHEN THESE SAMPLES WERE REPEATED, 19 OUT OF THE 21 GENERATED NEGATIVE RESULTS. RECOLLECTIONS OF THESE PATIENTS WERE TAKEN AND TESTED, AND AGAIN GENERATED POSITIVE RESULTS WITH SIMILAR CT VALUES AS SEEN DURING INITIAL TESTING. THESE RECOLLECTED SAMPLES WERE ALSO MEASURED BY LIGHT MIX E-GENE, AND 2 POSITIVES WERE GENERATED (19 NEGATIVE RESULTS). RESULTS WERE REPORTED AND NO HARM OR INJURY WAS INDICATED. AN INVESTIGATION WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. NINETEEN MDRS WILL BE FILED, ONE FOR EACH OF THE PATIENT SAMPLES GENERATING THE DISCREPANT RESULTS AS PER FDA REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814946 COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS 6800-8800 SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G23399

    Patients

    Seq Age Sex Outcome Treatment
    1