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: 12185248 · Received July 16, 2021

    Report

    Report Number
    2243471-2021-02558
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    May 17, 2021
    Report Date
    August 23, 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 MDRS 2243471-2021-01911-00, 2243471-2021-02538-00, 2243471-2021-02550-00, 2243471-2021-02548-00, AND 2243471-2021-02549-00 IT IS STATED THAT A TOTAL OF 5 MDRS WILL BE SUBMITTED. HOWEVER, A TOTAL OF 6 MDRS WILL BE SUBMITTED, ONE PER EACH SAMPLE. INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4)

    Additional Manufacturer Narrative · 0

    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 HAS BEEN LAUNCHED TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS. A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES WILL BE MADE AVAILABLE IN DUE COURSE. CONSIGNEES HAVE BEEN NOTIFIED. (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. THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FOR A COBAS® SARS-COV-2/INFLUENZA A/B ASSAY. A CUSTOMER FROM THE UNITED STATES ALLEGED THAT THEY RECEIVED POTENTIAL FALSE POSITIVE RESULTS FOR 5 PATIENT SAMPLES USING THE COBAS® SARS-COV-2/INFLUENZA A/B ASSAY. DURING REVIEW OF CUSTOMER-PROVIDED DATA IT WAS NOTICED THAT ON (B)(6) 2021 A PATIENT¿S SAMPLE ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED AN INFLUENZA B POSITIVE RESULT. THE PATIENT¿S SAME SAMPLE WAS REPEAT TESTED AND ANALYZED ON THE SAME COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. NEGATIVE RESULTS WERE REPORTED OUT. ON (B)(6) 2021 PATIENT #2 SAMPLE WAS ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B POSITIVE RESULT. THE PATIENT¿S SAME SAMPLE WAS REPEAT TESTED USING THE SIMPLEXA TEST THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. ORIGINAL POSITIVE AND RETEST NEGATIVE RESULTS REPORTED OUT. ON (B)(6) 2021 PATIENT #3 SAMPLE WAS ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 NEGATIVE AND INFLUENZA B POSITIVE RESULT. THE PATIENT¿S SAME SAMPLE WAS REPEAT TESTED ON THE SAME COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. THE NEGATIVE RESULTS WERE REPORTED OUT ON (B)(6) 2021 PATIENT #4 SAMPLE WAS ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 POSITIVE, INFLUENZA A NEGATIVE AND INFLUENZA B POSITIVE RESULT. THE PATIENT¿S SAME SAMPLE WAS REPEAT TESTED ON THE SAME COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. ORIGINAL POSITIVE AND RETEST NEGATIVE RESULTS REPORTED OUT. ON (B)(6) 2021 PATIENT #5 SAMPLE WAS ANALYZED ON THE COBAS LIAT SYSTEM (S/N (B)(4)) THAT GENERATED A SARS-COV-2 POSITIVE, INFLUENZA A POSITIVE AND INFLUENZA B POSITIVE RESULT. THE PATIENT¿S SAME SAMPLE WAS REPEAT TESTED ON A DIFFERENT COBAS LIAT SYSTEM (S/N NOT PROVIDED) THAT A SARS-COV-2 NEGATIVE, INFLUENZA A NEGATIVE AND INFLUENZA B NEGATIVE RESULT. ORIGINAL POSITIVE AND RETEST NEGATIVE RESULTS REPORTED OUT. PATIENT SAMPLE WAS COLLECTED USING NASAL AND NASOPHARYNGEAL SWABS AND VIRAL TRANSPORT MEDIA 3ML. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENT. THE INVESTIGATION TO ASSESS THE CUSTOMER ALLEGATION HAS NOT YET BEEN COMPLETED. SIX (6) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077778 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 10111Y

    Patients

    Seq Age Sex Outcome Treatment
    1