BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 - 192T

    MDR report key: 14631709 · Received June 8, 2022

    Report

    Report Number
    2243471-2022-00541
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 8, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. FROM THE INVESTIGATION PERFORMED, NO HARDWARE ISSUE WAS CONFIRMED TO BE CONTRIBUTING TO UNEXPECTED POSITIVE SAMPLES AS NO HARDWARE FLAGS OR REAGENT VOLUME FLAGS WERE FOUND IN THE PROVIDED PROBLEM REPORTS. IT IS SUSPECTED THAT THE PRE-ANALYTIC WORKFLOW OF THE CUSTOMER LED TO THE CONTAMINATION OF THE SECONDARY TUBES. 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 8800 SYSTEM IS THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA(B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST (192T) IS 09175431190 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 BRAZIL ALLEGED DISCREPANT RESULTS WHILE USING THE COBAS® SARS-COV-2 QUALITATIVE ASSAY FOR USE ON THE COBAS® 68/8800 SYSTEM. THE ALLEGED SARS COV-2 FULL RUN (94 SAMPLES) HAD ALL POSITIVE SAMPLE RESULTS. OUT OF 94 SAMPLES, ONLY ONE SAMPLE HAD A NEGATIVE RESULT. ANOTHER ALIQUOT WAS TAKEN FROM THE PRIMARY SAMPLE TUBES AND TESTED BY ANOTHER METHOD. FROM THE REPEAT RUN, ONLY 30% OF SAMPLES WERE RETESTED POSITIVE. THE SECOND RUN RESULTS WERE RELEASED BY THE LAB. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA GUIDANCE FOR EUA, A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL ALLEGED SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217799 COBAS® SARS-COV-2 - 192T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H24078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown