BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST - 480T

    MDR report key: 11941009 · Received June 4, 2021

    Report

    Report Number
    2243471-2021-01636
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 4, 2021
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION ON THE REAGENT KIT LOT WAS PERFORMED AND NO ISSUE WAS IDENTIFIED. AS THE COBAS LIAT TEST GENERATED A CT VALUE CLOSE TO THE LOD OF THAT ASSAY, IT IS LIKELY THAT THE COBAS 6800 ASSAY IS PERFORMING AS INTENDED, AS LOD SAMPLES ARE EXPECTED TO WAVER BETWEEN POSITIVE AND NEGATIVE RESULTS UPON RETEST, DUE TO THE NATURE OF THE ASSAY. (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 US ALLEGED A RESULT DISCREPANCY FOR A SINGLE SAMPLE TESTED WITH COBAS SARS-COV-2 QUALITATIVE ASSAY FOR USE ON THE COBAS 6800/8800 SYSTEMS COMPARED TO A RESULT GENERATED WHEN USING THE COBAS LIAT SARS-COV-2 AND INFLUENZA A/B TEST. THE CUSTOMER ALLEGED THE SAMPLE GENERATED A NEGATIVE SARS-COV-2 RESULT WITH COBAS SARS-COV-2 QUALITATIVE ASSAY FOR USE ON THE COBAS 6800/8800 SYSTEMS AND A POSITIVE SARS-COV-2 RESULT WHEN USING THE COBAS LIAT SARS-COV-2 AND INFLUENZA A/B TEST. THE NEGATIVE RESULT OBTAINED ON THE COBAS 6800 SYSTEM WAS NOT RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION ON THE REAGENT KIT LOT WAS PERFORMED AND NO ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839030 COBAS SARS-COV-2 TEST - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G32206

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR