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: 11988658 · Received June 12, 2021

    Report

    Report Number
    2243471-2021-01867
    Event Type
    Malfunction
    Date Received
    June 12, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 12, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    2243471-03-17-2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE COURSE OF THE INVESTIGATION, AN ADDITIONAL 4 FALSE POSITIVE SAMPLES WERE IDENTIFIED. REVIEW OF THE INSTRUMENT'S RUN DATA SHOWED THE ALLEGED RUN, PLUS THE 4 ADDITIONAL RUNS COULD BE POTENTIAL FALSE POSITIVES DUE TO ABNORMAL PCR GROWTH CURVES. ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE ON-GOING INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS, ABNORMAL PCR STEPS, AND LOOSE THERMAL SENSOR WIRING. OVERALL ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER IDENTIFY ERRORS AND DETECT ABNORMAL PCR CURVES WILL BE MADE AVAILABLE IN DUE COURSE. (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 THE US GENERATED 5 DISCREPANT RESULTS WITH THE COBAS® LIAT® SARS-COV-2/FLU TEST ON THE COBAS® LIAT® SYSTEM. INITIAL TEST RESULTS FROM SAMPLE 1 GENERATED SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE AND INFLUENZA B POSITIVE. UPON REPEAT TESTING OF THE SAME SAMPLE WITH ANOTHER COBAS® LIAT® SYSTEM SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE, AND INFLUENZA B NEGATIVE RESULTS WERE GENERATED. THE RESULTS OF THE REPEAT TESTING WERE REPORTED TO THE PATIENT. SAMPLE 2 GENERATED SARS-COV-2 POSITIVE, INFLUENZA A POSITIVE, AND INFLUENZA B POSITIVE RESULTS. SAMPLE 3 GENERATED INFLUENZA A POSITIVE RESULTS, SAMPLE 4 GENERATED SARS-COV-2 POSITIVE- INFLUENZA B POSITIVE, AND SAMPLE 5 GENERATED INFLUENZA B POSITIVE RESULT. SAMPLES WERE COLLECTED USING NASOPHARYNGEAL SAMPLES WITH GENERAL TRANSPORT MEDIA. THE METHOD SHEET INDICATES THE TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2, INFLUENZA A AND INFLUENZA B RNA IN NASAL AND NASOPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM (UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) OR THERMO FISHER¿ SCIENTIFIC REMEL¿ MEDIA, OR THOMAS SCIENTIFIC MANTACC¿ PREMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULTS. NO HARM IS ALLEGED, AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER THE FDA GUIDANCE FIVE (5) MDRS WILL BE FILED; ONE FOR EACH PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885346 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 10322U

    Patients

    Seq Age Sex Outcome Treatment
    1