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: 12178772 · Received July 15, 2021

    Report

    Report Number
    2243471-2021-02502
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 15, 2021
    Report Date
    September 3, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO PROVIDE THE INVESTIGATION CONCLUSION FOR 2243471-2021-02503-00. AN INVESTIGATION WAS PERFORMED AND NO PRODUCT PROBLEM WAS FOUND. FOR THE FIVE ALLEGED RUNS, THE PCR CURVE FOR SARS-COV-2 SHOWED A REAL AMPLIFICATION ON THE RAW PDAT DATA AND A CLEAR EXPONENTIAL ELEVATION OF THE PCR GROWTH CURVE, THUS IT COULD NOT BE CONFIRMED AS FALSE POSITIVE, ADDITIONALLY THREE OUT OF THE FIVE ALLEGED RUNS (RUN # 928, 961 AND 1037) WERE IDENTIFIED AS LOW TITER. THERE WAS NO EVIDENCE OF A HARDWARE ISSUE NOR A TUBE LEAKAGE. ALL RUNS SHOWED CLEAR AMPLIFICATION IN THE GROWTH CURVE AND APPEAR TO BE REAL POSITIVE SAMPLES. THE ANALYZER WAS PERFORMING WELL AND NO SUSPECTED FALSE RESULTS WERE SEEN IN THE DATA SET. IT IS KNOWN LIMIT OF DETECTION (LOD) SAMPLES CAN PRODUCE DISCREPANT RESULTS UPON REPEAT TESTING. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS A CORRECTION. PLEASE NOTE THAT 2243471-2021-02502-02 WAS SUBMITTED IN ERROR AS A FOLLOW UP OF 2243471-2021-02503-00 AND IS A DUPLICATE OF MFR REPORT NO. 2243471-2021-02502-01. (B)(4).

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM (B)(6) ALLEGED A DISCREPANT RESULT FOR A FIVE PATIENT SAMPLES, WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. NO HARM WAS ALLEGED. THE PCR CURVE FOR COVID SHOWED A REAL AMPLIFICATION AND A CLEAR EXPONENTIAL ELEVATION OF THE PCR GROWTH CURVE, THUS IT CAN NOT BE CONFIRMED TO BE CALLED A FALSE POSITIVE. AN INVESTIGATION HAS BEEN INITIATED AND IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO PROVIDE THE INVESTIGATION CONCLUSION FOR 2243471-2021-02502-00. AN INVESTIGATION WAS PERFORMED AND NO PRODUCT PROBLEM WAS FOUND. FOR THE FIVE ALLEGED RUNS, THE PCR CURVE FOR SARS-COV-2 SHOWED A REAL AMPLIFICATION ON THE RAW PDAT DATA AND A CLEAR EXPONENTIAL ELEVATION OF THE PCR GROWTH CURVE, THUS IT COULD NOT BE CONFIRMED AS FALSE POSITIVE, ADDITIONALLY THREE OUT OF THE FIVE ALLEGED RUNS (RUN # 928, 961 AND 1037) WERE IDENTIFIED AS LOW TITER. THERE WAS NO EVIDENCE OF A HARDWARE ISSUE NOR A TUBE LEAKAGE. ALL RUNS SHOWED CLEAR AMPLIFICATION IN THE GROWTH CURVE AND APPEAR TO BE REAL POSITIVE SAMPLES. THE ANALYZER WAS PERFORMING WELL AND NO SUSPECTED FALSE RESULTS WERE SEEN IN THE DATA SET. IT IS KNOWN LIMIT OF DETECTION (LOD) SAMPLES CAN PRODUCE DISCREPANT RESULTS UPON REPEAT TESTING. (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 FROM (B)(6) ALLEGED A DISCREPANT RESULT FOR FIVE PATIENT SAMPLES WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. ACCORDINGLY, 5 MDRS WILL BE FILED PER THE FDA GUIDANCE. ALL 5 SAMPLES GENERATED A POSITIVE SARS-COV-2 RESULT UPON INITIAL TESTING ON LIAT. A RETEST WAS PERFORMED BY RECOLLECTING NEW SAMPLES FROM ALL FIVE PATIENTS AND A NEGATIVE RESULT WAS OBTAINED FOR ALL. THE POSITIVE RESULTS WERE NOT RELEASED AND NO HARM WAS ALLEGED. AN INVESTIGATION HAS BEEN INITIATED AND IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074512 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 10308Y

    Patients

    Seq Age Sex Outcome Treatment
    1