BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST

    MDR report key: 11340568 · Received February 17, 2021

    Report

    Report Number
    2243471-2021-00346
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 17, 2021
    Report Date
    February 17, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON THE REAGENT KIT LOT AND NO PRODUCT PROBLEM WAS IDENTIFIED. BASED ON THE INFORMATION AND DATA PROVIDED AND THE INVESTIGATION PERFORMED THERE IS NO INDICATION THE PRODUCT IS NOT FUNCTIONING AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    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 IN (B)(6) ALLEGED DISCREPANT RESULTS WITH COBAS® SARS-COV-2 TEST FOR USE ON THE COBAS 6800/8800 SYSTEM. TWO DIFFERENT PATIENT SAMPLES FROM 2 DIFFERENT CONSECUTIVES RUNS RETURNED A TARGET 1 POSITIVE, TARGET 2 NEGATIVE SARS-COV-2 RESULT. THE POSITIVE RESULT WAS REPORTED TO THE PATIENT. THE SAMPLES WERE SENT TO A REFERENCE LABORATORY FOR CONFIRMATORY TESTING, WHICH USES AN IN HOUSE ASSAY THAT TARGETS THE N, S AND RDRP/HELICASE GENES. THE SAMPLES WERE TESTED IN DUPLICATE, AND BOTH RETURNED NEGATIVE RESULTS. FOLLOWING THE NEGATIVE CONFIRMATORY TESTING, THE ORIGINAL RESULTS FOR BOTH PATIENTS WERE AMENDED TO INCLUDE A C-NOTE STATING THAT WHILE REACTIVITY WAS DETECTED IN THE COBAS 6800/8800 SARS-COV-2 TEST, THE CONFIRMATORY TESTING RESULTS WERE NEGATIVE. THE SAMPLE TYPE FOR THESE SAMPLES WAS SALIVA. THE CUSTOMER IS FULLY AWARE THIS IS AN OFF-LABEL SAMPLE TYPE AND HAVE VALIDATED SALIVA SAMPLES INTERNALLY. TO FURTHER THE INVESTIGATION ADDITIONAL SAMPLES WERE COLLECTED VIA NASAL AND THROAT SWABS. THE NASAL AND THROAT SWABS WERE TESTED ON THE GENEXPERT AND THE C6800/8800 SARS-COV-2 TEST AS WELL AS THE REFERENCE LABORATORY¿S IN HOUSE SARS-COV-2 ASSAY. ALL TESTING RETURNED NEGATIVE RESULTS. NO HARM TO BOTH PATIENTS WAS ALLEGED. AS 2 SAMPLES FROM 2 PATIENTS ARE ALLEGED, AND AS RESULTS WERE REPORTED OUT, 2 MDRS WILL BE NEEDED. INVESTIGATION FROM THE REVIEW OF DATA PROVIDED BY CUSTOMER DID NOT IDENTIFY ANY PRODUCT PROBLEM. THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800/8800 SYSTEMS IS A REAL-TIME RT-PCR TEST INTENDED FOR THE QUALITATIVE DETECTION OF NUCLEIC ACIDS FROM SARS-COV-2 IN CLINICIAN-INSTRUCTED SELF-COLLECTED NASAL SWAB SPECIMENS (COLLECTED ON SITE), AND CLINICIAN-COLLECTED NASAL, NASOPHARYNGEAL, AND OROPHARYNGEAL SWAB SPECIMENS FROM INDIVIDUALS WHO MEET COVID-19 CLINICAL AND/OR EPIDEMIOLOGICAL CRITERIA. THE COBAS SARS-COV-2 IS A QUALITATIVE TEST FOR USE ON THE COBAS 6800/8800 SYSTEM FOR THE DETECTION OF THE 2019 NOVEL CORONAVIRUS(SARS-COV-2) RNA IN NASAL, NASOPHARYNGEAL, AND OROPHARYNGEAL SWAB SAMPLES COLLECTED IN COPAN UNIVERSAL TRANSPORT MEDIUM SYSTEM (UTM-RT),BD UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT), COBAS PCR MEDIA, OR 0.9% PHYSIOLOGICAL SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236638 COBAS SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G26033

    Patients

    Seq Age Sex Outcome Treatment
    1