BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST

    MDR report key: 11008002 · Received December 15, 2020

    Report

    Report Number
    2243471-2020-00459
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    April 28, 2020
    Report Date
    December 14, 2020
    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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH THE COURSE OF THE INVESTIGATION, A PRODUCT NON-CONFORMANCE WAS NOT IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    THE AGENCY HAS CLARIFIED ITS EXPECTATION THAT MANUFACTURERS OF EMERGENCY USE AUTHORIZATION (EUA) PRODUCTS FOR SARS-COV-2 DIAGNOSTIC TESTS REPORT ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE BEYOND 803S REASONABLY SUGGESTS REQUIREMENTS. ACCORDINGLY, WE HAVE PERFORMED A RETROSPECTIVE REVIEW OF CASES TO DETERMINE WHETHER TO REPORT ANY ADDITIONAL CASES. A (B)(6) CUSTOMER ALLEGED DISCREPANT RESULTS FOR 2 PATIENT SAMPLES BETWEEN THE COBAS SARS-COV-2 AND A LAB DEVELOPED TEST (LDT) FOR SARS-COV-2. THE SAMPLES WERE NASOPHARYNGEAL SAMPLES COLLECTED IN UTM. ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE 2 SAMPLES IN QUESTION BOTH ARE REPEATABLE WITH THE SAME RESULT WHEN TESTED WITH COBAS SARS-COV-2 TEST. THE DISCREPANT RESULTS WERE ONLY OBSERVED WHEN THESE 2 SAMPLES WERE TESTED WITH THE LAB DEVELOPED TEST (LDT). THE DISCREPANT RESULTS ARE LIKELY SAMPLE SPECIFIC IN WHICH THE TECHNOLOGY DIFFERENCES, SUCH AS LIMITS OF DETECTION AND SPECIFICITY, COULD ALSO BE A CONTRIBUTING FACTOR. NO PRODUCT PROBLEM WAS IDENTIFIED DURING THE COURSE OF THE INVESTIGATION. BOTH SAMPLES ARE LIKELY AT THE LOD WHICH IS RESULTING IN THE EXPECTED WAVERING RESULTS WHEN TESTED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471843 COBAS SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G06563

    Patients

    Seq Age Sex Outcome Treatment
    1