BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    MDR report key: 12503046 · Received September 20, 2021

    Report

    Report Number
    2243471-2021-03316
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 22, 2021
    Report Date
    October 21, 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

    THE CUSTOMER'S COBAS LIAT ANALYZER (S/N(B)(4)) WAS RETURNED FOR EVALUATION AND REPAIR. INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS LIAT SYSTEM, PRODUCT CODE: OCC CATALOG NUMBER07341920190 AND UDI (B)(4). THE TEST USED ON THE COBAS LIAT SYSTEM IS THE COBAS SARS-COV-2 & INFLUENZA A/B TEST PRODUCT CODE QJR, CATALOG NUMBER 09211101190 AND UDI. (B)(4). (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COBAS LIAT ANALYZER (S/N (B)(4)) WAS RETURNED FOR EVALUATION AND REPAIR. FROM THE DATA INSPECTION, IT WAS IDENTIFIED THAT THERE WAS ISSUES ASSOCIATED WITH ABNORMAL PCR 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 TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES HAVE BEEN LAUNCHED. THE IMPLEMENTATION OF BOTH THE SOFTWARE AND THE UPDATED SCRIPT HAVE SHOWN A REDUCTION IN THE CALCULATED FALSE POSITIVE RATE. CONSIGNEES HAVE BEEN NOTIFIED. (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FROM A COBAS® LIAT® SYSTEM (S/N16875). A CUSTOMER FROM THE UNITED STATES ALLEGED THAT THEY RECEIVED POTENTIAL FALSE POSITIVE RESULTS FOR 2 PATIENTS¿ SAMPLES WHEN TESTED WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY ANALYZED ON THE COBAS® LIAT® SYSTEM (S/N(B)(4)). THE CUSTOMER REPORTED THAT ON (B)(6), 2021 RUNS #1769 GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A POSITIVE, INFLUENZA B NEGATIVE RESULT FOR ONE PATIENT. THE PATIENT¿S SAME SAMPLE WAS REPEAT TESTED ON A DIFFERENT ASSAY THE FABA ANALYZED ON THE COBAS® LIAT® SYSTEM (S/N(B)(4)) THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULT. A SECOND REPEAT OF THE PATIENT¿S SAME SAMPLE WITH THE SCFA ASSAY ANALYZED ON THE COBAS® LIAT® SYSTEM (S/N(B)(4)) ALSO GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULT. RUN #1773 GENERATED AN INFLUENZA A POSITIVE RESULT FOR A SECOND PATIENT¿S SAMPLE. A RECOLLECTED SAMPLE FOR THE 2ND PATIENT WAS TESTED ON A DIFFERENT COBAS® LIAT® SYSTEM (S/N NOT PROVIDED) THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE, INFLUENZA B NEGATIVE RESULT. PATIENTS' SAMPLES WERE COLLECTED USING NASOPHARYNGEAL IN REMEL MICROTEST M4RT 3 ML. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENTS. THE INFLUENZA A POSITIVE RESULT WAS REPORTED OUT TO PATIENT #1 AND/OR PERSONNEL TREATING THE PATIENT. THE NEGATIVE RESULT FOR PATIENT #2 WAS REPORTED OUT TO THE PATIENT AND/OR PERSONNEL TREATING THE PATIENT. THE INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION HAS NOT YET BEEN COMPLETED. TWO (2) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400167 COBAS LIAT SARS-COV-2 & INFLUENZA A/B REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1