BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 - 480T

    MDR report key: 13568871 · Received February 21, 2022

    Report

    Report Number
    2243471-2022-00235
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 21, 2022
    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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH REQUESTED, NO DATA WAS PROVIDED FOR FURTHER ANALYSIS. NO PRODUCT PROBLEM IS SUSPECTED SINCE THE CUSTOMER WAS ALSO EXPERIENCING INVALID NEGATIVE CONTROL REPLICATES DUE TO THE GENERATION OF POSITIVE RESULTS, WHICH RESOLVED AFTER THE INSTRUMENT WAS CLEANED. THE CUSTOMER CONFIRMED THE SYSTEM IS NOW RUNNING AS EXPECTED. NO ISSUES WERE IDENTIFIED WITH THE COMPLAINT KIT LOT (H26149). THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 6800 SYSTEM (PRODUCT CATALOG NUMBER 05524245001; UDI: (B)(4); PMA 510K: BK140196; PRODUCT CODE: MZA). THE TEST USED ON THE COBAS 6800 SYSTEM IS THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA(B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST (480T) IS 09343733190 AND THE UDI IS (B)(4). INITIAL REPORTER FACILITY NAME (HOSP. UNIV. (B)(6) HOSP. (B)(6)) WAS TRUNCATED DUE TO CHARACTER LIMITATIONS. (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 IN SPAIN ALLEGED THE GENERATION OF POTENTIAL FALSE POSITIVE RESULTS FOR 88 SAMPLES, INCLUDED IN ONE SPECIFIC RUN BATCH (804), TESTED WITH THE COBAS® SARS-COV-2 - 480T. UPON RETESTING ON ANOTHER INSTRUMENT (UNKNOWN PLATFORM) ALL SAMPLES WERE NEGATIVE. NO HARM OR INJURY WAS INDICATED AND IT WAS CONFIRMED THAT NO ERRONEOUS RESULTS WERE REPORTED OUT. THE CUSTOMER ALSO HAD TWO INVALID RUNS BECAUSE THE NEGATIVE CONTROL REPLICATES GENERATED POSITIVE RESULTS AS WELL. SUBSEQUENT TO THESE RUNS, THE LOCAL FIELD SPECIALIST VISITED THE SITE AND PERFORMED A DECONTAMINATION OF THE SYSTEM; A SUBSEQUENT WATER RUN WAS PERFORMED AND NO FALSE POSITIVE RESULTS WERE GENERATED. A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL THE SAMPLES ON THE ALLEGED RUN. THIS WILL REPRESENT ONE EVENT ON A SINGLE DEVICE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129102 COBAS® SARS-COV-2 - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H26149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown