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: 12264594 · Received August 2, 2021

    Report

    Report Number
    2243471-2021-02812
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 4, 2021
    Report Date
    August 2, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). REVIEW OF THE PROVIDED DATA CONFIRMED THAT POTENTIAL FALSE POSITIVE CALLS WERE MADE DUE TO ABNORMAL PCR GROWTH CURVES FOR THE FOLLOWING RUNS: 1 RUN (#(B)(6)), ASSAY TUBE LOT 10308Y (D38Y), WAS FOUND TO HAVE MADE POTENTIAL FALSE POSITIVE CALLS FOR SARS-COV-2, FLU A AND FLU B. 1 RUN (#(B)(6)), ASSAY TUBE LOT 10308Y (D38Y), WAS FOUND TO HAVE MADE POTENTIAL FALSE POSITIVE CALL FOR FLU B. IT IS RECOMMENDED TO SEND THIS ANALYZER TO EMEA REGIONAL REPAIR CENTER (ERRC) - (B)(6) FOR DECONTAMINATION/REPAIR. 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. A CUSTOMER FROM GREAT BRITAIN ALLEGED DISCREPANT RESULTS GENERATED WHEN TESTED USING THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY ANALYZED WITH THE COBAS® LIAT SYSTEM. THE INITIAL RUN #(B)(6) LOT 10308Y (D38Y) GENERATED SARS-COV-2 POSITIVE, FLU A POSITIVE, FLU B POSITIVE. WHILE RUN # (B)(6) GENERATED SARS-COV-2 POSITIVE, FLU A NEGATIVE AND FLU B POSITIVE. NO HARM IS ALLEGED. ALTHOUGH REQUESTED, IT IS UNKNOWN WHETHER ANY RETEST OF THE SAMPLES WERE PERFORMED AND OR WHAT REAGENT LOT WAS USED. THE RESULTS WERE NOT REPORTED TO THE PATIENT. CUSTOMER COLLECTED NASOPHARYNGEAL AND THROAT SAMPLES WITH THE GREEN FALCON TUBE OR PRIME STORE TUBE, FLOWQ SWAB, WHICH IS AN OFF-LABEL COLLECTION KIT, FOR APPROVED COLLECTION KITS, THE METHOD SHEET STATES: THIS 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. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER¿S ALLEGATION. PER THE FDA GUIDANCE TWO (2) MDRS WILL BE FILED, ONE (1) PER EACH SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160972 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