BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 12278694 · Received August 4, 2021

    Report

    Report Number
    2243471-2021-02833
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM BELGIUM ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. AN INVESTIGATION IS ONGOING TO EVALUATE THE CUSTOMER ISSUE. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO 2243471-2021-02833 TO PROVIDE THE INVESTIGATION CONCLUSION FOR (B)(4). AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE WHICH DID NOT IDENTIFY A PRODUCT PROBLEM. REVIEW OF THE DATA INDICATED THAT THE LIAT RUN HAD MODERATE TARGET AMPLIFICATION AND ROBUST INTERNAL CONTROL AMPLIFICATION. THERE IS NO INDICATION OF PCR INHIBITION OR CURVE ABNORMALITIES. THE LIAT RESULT IS FURTHER SUPPORTED BY THE OTHER POSITIVE RESULTS GENERATED ON THE DIFFERENT PLATFORMS. THE DISCREPANCY IS LIKELY DUE TO DIFFERENCES IN METHOD ALGORITHMS AND/OR SENSITIVITIES BETWEEN THE PLATFORMS USED.

    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 BELGIUM ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. THE ALLEGED NASOPHARYNGEAL SAMPLE GENERATED A POSITIVE SARS-COV-2 RESULT BOTH ON THE LIAT INSTRUMENT AND A DIFFERENT PLATFORM. THE SAME SAMPLE WAS TESTED ON A THIRD SYSTEM WHICH WAS NEGATIVE. ADDITIONALLY, A SALIVA SAMPLE WAS TESTED ON ANOTHER PLATFORM AND WAS LIKEWISE POSITIVE. NOTE, THE CUSTOMER BELIEVES THE NON-LIAT NEGATIVE RESULT TO BE DISCREPANT. AN INVESTIGATION IS ONGOING TO EVALUATE THE CUSTOMER ISSUE.

    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 BELGIUM ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. THE ALLEGED NASOPHARYNGEAL SAMPLE GENERATED A POSITIVE SARS-COV-2 RESULT BOTH ON THE LIAT INSTRUMENT AND A DIFFERENT PLATFORM. THE SAME SAMPLE WAS TESTED ON A THIRD SYSTEM WHICH WAS NEGATIVE. ADDITIONALLY, A SALIVA SAMPLE WAS TESTED ON ANOTHER PLATFORM AND WAS LIKEWISE POSITIVE. NOTE, THE CUSTOMER BELIEVES THE NON-LIAT NEGATIVE RESULT TO BE DISCREPANT. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE WHICH DID NOT IDENTIFY A PRODUCT PROBLEM. REVIEW OF THE DATA INDICATED THAT THE LIAT RUN HAD MODERATE TARGET AMPLIFICATION AND ROBUST INTERNAL CONTROL AMPLIFICATION. THERE IS NO INDICATION OF PCR INHIBITION OR CURVE ABNORMALITIES. THE LIAT RESULT IS FURTHER SUPPORTED BY THE OTHER POSITIVE RESULTS GENERATED ON THE DIFFERENT PLATFORMS. THE DISCREPANCY IS LIKELY DUE TO DIFFERENCES IN METHOD ALGORITHMS AND/OR SENSITIVITIES BETWEEN THE PLATFORMS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174888 COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10413X

    Patients

    Seq Age Sex Outcome Treatment
    1