BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SYSTEM

    MDR report key: 11704582 · Received April 21, 2021

    Report

    Report Number
    2243471-2021-00909
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 24, 2021
    Report Date
    October 22, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OCC
    PMA / PMN Number
    K111387
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE CONCLUSIONS ARE AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO PROVIDE THE CASE CONCLUSION FOR 2243471-2021-00909-00. AN INVESTIGATION WAS PERFORMED TO EVALUATE THE CUSTOMER ISSUE. ROCHE IDENTIFIED SELECT COBAS LIAT ANALYZERS ARE GENERATING FALSE POSITIVE FLU B RESULTS DUE TO NOISY PHOTOMETER SIGNALS IN THE SPECIFIC CHANNEL THAT DETECTS FLU B. OVERALL, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY TO OCCUR DUE TO THE CLINICAL MITIGATIONS THAT EXIST AND THE LOW OCCURRENCE RATE OF THE ISSUE. ROCHE IS IN THE PROCESS OF REPLACING THE PHOTOMETER ASSEMBLIES IN THE AFFECTED INSTRUMENTS. (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. TWENTY-SEVEN (27) PATIENT SAMPLES RUN ON A SPECIFIC COBAS LIAT ANALYZER (SERIAL ID (B)(4)), WERE IDENTIFIED AS FALSE POSITIVE FOR FLU B BASED ON REVIEW OF DATA PROVIDED THROUGH A CUSTOMER ALLEGATION OF A HIGH NUMBER OF QUESTIONED RESULTS AND INVALIDS WHILE RUNNING COBAS SARS-COV-2 & INFLUENZA A/B ASSAY ACROSS MULTIPLE LIAT ANALYZERS. THE CUSTOMER REPORTED THAT SOME OF THESE ORIGINAL FLU B POSITIVE ONLY SAMPLES WERE USED FOR REPEAT TESTING WHICH WAS ALSO PERFORMED ON LIAT ANALYZERS WITH THE COBAS SARS-COV-2 & INFLUENZA A/B ASSAY. THE RESULTS WERE NOT RELEASED TO THE PATIENT AND/OR THE PHYSICIAN AND THE PATIENTS WERE NOT TREATED BASED ON THE POSITIVE FLU B RESULTS UNLESS REPEAT LIAT TESTING CONFIRMED POSITIVE RESULTS. THERE IS NO INDICATION OF HARM. THE SAMPLES WERE COLLECTED USING 3ML UTM-RT (CATALOG NUMBER 220531, EXPIRATION DATE: 4/2022) AND STORED AT 2-8 DEGREES CELSIUS. TWENTY SEVEN (27) MDRS, ONE PER EACH FALSE POSITIVE PATIENT SAMPLE, WILL BE FILED PER THE FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596150 COBAS LIAT SYSTEM RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM OCC ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1