BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 14716850 · Received June 16, 2022

    Report

    Report Number
    2243471-2022-00567
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 13, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OCC
    PMA / PMN Number
    K111387
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION. FACILITY NAME: THE FACILITY'S FULL NAME "(B)(6) LABORATORIES LTD (B)(6) LABORATORIES" HAS BEEN TRUNCATED DUE TO CHARACTER LIMITATIONS.

    Additional Manufacturer Narrative · 0

    THE ANALYZER IS PERFORMING STABLE AND AS EXPECTED FOR THE WHOLE DATASET. THERE IS NO HARDWARE PROBLEM IDENTIFIED THAT COULD HAVE HAD AN IMPACT ON RESULT INTERPRETATION. TRUE AMPLIFICATION WAS OBSERVED FOR THE SARS-COV-2 TARGET AND NO PRODUCT PROBLEM WAS IDENTIFIED. ALTHOUGH ROOT CAUSE COULD NOT BE CONFIRMED, IT IS POSSIBLE THAT THE DISCREPANCY IS DUE TO SAMPLE HANDLING/MIX-UP AT THE CUSTOMER SITE AS MANY OTHER STRONG POSITIVE SAMPLES WERE OBSERVED IN THE CUSTOMERS DATASET. THE REAGENT LOT USED WAS TESTED INTERNALLY AND THE COMPLAINT ALLEGATION WAS NOT OBSERVED. NO PRODUCT PROBLEM RELATED TO THE CUSTOMER ALLEGATION WAS IDENTIFIED.

    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 FROM TAIWAN ALLEGED DISCREPANT RESULTS FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED NEGATIVE RESULTS FOR SARS-COV-2, INFLUENZA A, AND INFLUENZA B. THE SAME SAMPLE WAS RETESTED ON THE SAME COBAS® LIAT® SYSTEM WHICH YIELDED A POSITIVE RESULT FOR SARS-COV-2 AND A NEGATIVE RESULT FOR INFLUENZA A AND INFLUENZA B. THE POSITIVE RESULT WAS RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION IS IN PROGRESS TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 1 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092228 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES OCC ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20207Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown