BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SYSTEM

    MDR report key: 11579953 · Received March 27, 2021

    Report

    Report Number
    2243471-2021-00602
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    February 16, 2021
    Report Date
    May 6, 2021
    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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION ABOUT ALLEGATION RESULTS HAS BEEN REQUESTED BUT NOT PROVIDED . A FOLLOW UP REPORT WILL BE FILED WITH THE OUTCOME OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS MDR (2243471-2021-00602) IS CONSIDERED A DUPLICATE OF 2243471-2021-00600. THE DEVICE EVALUATION FOR THIS CUSTOMER ALLEGATION WAS CAPTURED IN THE SUPPLEMENT ASSOCIATED WITH 2243471-2021-00600. (B)(4).

    Description of Event or Problem · 1

    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. THE CUSTOMER ALLEGED DISCREPANT RESULTS FOR A PATIENT ON THE COBAS® SARS-COV-2 ASSAY. A CUSTOMER FROM (B)(6) ALLEGED 5 POTENTIAL FALSE POSITIVE SAMPLES FOR SARS-COV-2 ON LAIT ANALYZER (SN (B)(4)). ALL 5 ALLEGED RUNS WERE CONFIRMED TO BE FALSE POSITIVES EVEN THOUGH SOME OF THESE RUNS SHOW AN INCREASE IN THE SARS-COV-2 TARGET SIGNAL. TWO OF THE SAMPLES WERE RERUN ON THE GENEXPERT AND RESULTS WERE NOT AVAILABLE. THREE SAMPLES WERE FOUND NEGATIVE IN CONFIRMING PCR ON ANOTHER PLATFORM AND NO RESULTS ARE AVAILABLE. ALL POSITIVES RESULTS USE A "VARIANT-PCR" TO DIFFERENTIATE TYPE. THE CUSTOMER CONFIRMED THAT THERE WAS NO ALLEGATIONS OF HARM TO THE PATIENT. THE INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION HAS NOT YET BEEN COMPLETED. 5 MDRS WILL BE FILED, ONE FOR EACH OF THE SAMPLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476739 COBAS LIAT SYSTEM RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM OCC ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 00624X

    Patients

    Seq Age Sex Outcome Treatment
    1