BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 - 480T

    MDR report key: 12924317 · Received December 3, 2021

    Report

    Report Number
    2243471-2021-03830
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 2, 2021
    Report Date
    December 3, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA REVIEW SHOWED THAT THE SAMPLES ARE NEAR OR BELOW THE LOD. THEREFORE IT IS NOT UNLIKELY THAT REPEATED TESTING WITH THE COBAS® 6800 MAY GENERATE A NEGATIVE RESULT, AS LOD SAMPLES CAN BE EXPECTED TO WAIVER BETWEEN POSITIVE AND NEGATIVE DETECTION. ALTHOUGH A DEFINITE ROOT CAUSE CANNOT BE PINPOINTED, WE CANNOT RULE OUT A MINOR CONTAMINATION EVENT OCCURRING IN THE FIRST ROUND OF TESTING, WHICH MAY BE MORE PLAUSIBLY, AS THE CURVES FOR THESE SAMPLES WERE VERY FLAT WITH A SUPPRESSED IC CURVE. ALSO, THE SAMPLES COMPARED ARE FROM DIFFERENT COLLECTIONS AND IT IS POSSIBLE THAT THE ALREADY LOW VIRAL LOAD CHANGED AS DAYS PASSED. ALSO THE DIFFERENCES IN TECHNOLOGY BETWEEN THE ROCHE AND NON-ROCHE ASSAYS MUST BE TAKEN INTO ACCOUNT. (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. CUSTOMER ALLEGED 11 SAMPLES, WHEN USING THE KIT COBAS 6800/8800 SARS-COV-2 480T ANALYZED ON THE COBAS® 6800. HOWEVER ONLY 8 PATIENT IDS WERE PROVIDED FOR WITHIN 5 BATCHES. 5 BATCH MDRS ARE BEING SUBMITTED TO REPRESENT BATCH RUNS # (B)(6). THE CUSTOMER REPORTED THAT MULTIPLE SAMPLES WERE TESTED POSITIVE WITH A LATE CT IN EITHER TARGET 1 OR TARGET 2, BUT TESTED NEGATIVE ON A DIFFERENT PLATFORM. BATCH RUN #(B)(6) WAS RETESTED AS NEGATIVE WITH THE COBAS 6800 AND PANTHER. BATCH RUN #234(B)(6) AS NEGATIVE WITH THE PANTHER AND SEEGENE; BATCH RUN #(B)(6) WAS RETESTED AS NEGATIVE WITH THE PANTHER AND 6800; BATCH RUN # (B)(6) WAS RETESTED NEGATIVE WITH THE COBAS 6800 AND SEEGENE. THE SAMPLES WERE REPORTED AS INDETERMINATE. THE SAMPLE COLLECTION TYPE IS UNKNOWN, THE MEDIA TYPE WAS 2.5 ML EDWARDS VIRAL TRANSPORT FLUID. THE METHOD SHEET INDICATES THAT ; THIS TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2, INFLUENZA A AND INFLUENZA B RNA IN NASAL AND NASOPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM (UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) OR THERMO FISHER¿ SCIENTIFIC REMEL¿ MEDIA, OR THOMAS SCIENTIFIC MANTACC¿ PREMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULTS. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. PER THE FDA GUIDANCE FIVE (5) MDRS WILL BE FILED ONE PER RUN. EACH BATCH WILL REPRESENT ONE EVENT ON A SINGLE DEVICE. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827514 COBAS® SARS-COV-2 - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H01496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown