BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 TEST

    MDR report key: 11198037 · Received January 19, 2021

    Report

    Report Number
    2243471-2021-00109
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    June 27, 2020
    Report Date
    January 19, 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
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) ALLEGED RESULT DISCREPANCIES WITH SAMPLES FROM A SINGLE PATIENT TESTED WITH THE COBAS® SARS-COV-2 TEST. NO HARM WAS ALLEGED. BASED ON THE PROVIDED INFORMATION AND DATA, THE PRE-ANALYTICAL WORKFLOW IS SUSPECTED OF IMPACTING THE RESULTS AS THE SAMPLES WERE COLLECTED ON DIFFERENT DATES WITH DIFFERENT COLLECTION TUBES IN UNKNOWN MEDIA TYPES. AN INVESTIGATION WAS PERFORMED TO RULE OUT REAGENT CONTRIBUTION AND NO PRODUCT PROBLEM WAS 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 803¿S REASONABLY SUGGESTS REQUIREMENTS. ACCORDINGLY, WE HAVE PERFORMED A RETROSPECTIVE REVIEW OF CASES TO DETERMINE WHETHER TO REPORT ANY ADDITIONAL CASES. A CUSTOMER FROM EGYPT ALLEGED RESULT DISCREPANCIES WITH SAMPLES FROM A SINGLE PATIENT TESTED WITH THE COBAS® SARS-COV-2 TEST. THE ORIGINAL PATIENT SAMPLE (SWAB 1) GENERATED A POSITIVE RESULT. UPON PATIENT ADMISSION TO INPATIENT CARE, A SECOND SAMPLE (SWAB 2) WAS COLLECTED WHICH RETURNED A NEGATIVE RESULT. BOTH PATIENT SAMPLES 1 AND 2 WERE RETESTED, AND AGAIN, RETURNED A POSITIVE AND NEGATIVE RESULT RESPECTIVELY. NO HARM WAS ALLEGED IN THE CASE AND NO FURTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED. REGARDING WORKFLOW, THE SAMPLES WERE NASAL SPECIMENS BUT COLLECTED WITH WOVEN SWABS IN TWO DIFFERENT COLLECTION TUBES; DISPOSABLE COLLECTION TUBES FROM CHINA. THEY WERE ALSO FROM SEPARATE COLLECTIONS; SWAB 1 ON (B)(6) AND SWAB 2 ON (B)(6). THE SAMPLES WERE COLLECTED IN 3ML COLLECTION MEDIA AND 700 UL WAS TRANSFERRED TO THE SECONDARY TUBE AND STORED AT 25°C FOR THE RETEST. NO MANIPULATION OF THE TUBES WAS PERFORMED SINCE THE INITIAL TESTING. A REVIEW OF THE GROWTH CURVES DID NOT SHOW ANY ABNORMALITIES. THE ROCHE CONTROLS WERE IN LINE WITH RELEASE DATA. SWAB 2 GENERATED CONSISTENT NEGATIVE RESULTS INDICATING AN ISSUE WITH THIS COLLECTION AS SWAB 1 GENERATED A POSITIVE RESULT WITH ROBUST CT VALUES FOR BOTH TARGETS. REGARDING THE DIFFERENT CT VALUES BETWEEN THE POSITIVE RESULTS IN INITIAL AND REPEAT TESTING FOR SWAB 1, IT IS POSSIBLE THE SAMPLE MAY HAVE DEGRADED AS IT WAS STORED AT 25°C FOR 4 DAYS AS IT SHOWED DELAYED TARGET CT VALUES AND SUPPRESSED RFI VALUES. ALTHOUGH SAMPLE STABILITY WHEN USING THE TEST HAS NOT BEEN ESTABLISHED, THE SAMPLE SHOULD HAVE BEEN STORED FROZEN WHEN NOT TESTED WITH 48 HOURS AS PER THE METHOD SHEET. BASED ON THE PROVIDED INFORMATION AND DATA, THE PRE-ANALYTICAL WORKFLOW IS SUSPECTED OF IMPACTING THE RESULTS AS THE SAMPLES WERE COLLECTED ON DIFFERENT DATES WITH DIFFERENT COLLECTION TUBES IN UNKNOWN MEDIA TYPES. AN INVESTIGATION WAS PERFORMED TO RULE OUT REAGENT CONTRIBUTION WHICH IDENTIFIED NO PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88909 COBAS SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA G09200

    Patients

    Seq Age Sex Outcome Treatment
    1