BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12739798 · Received November 2, 2021

    Report

    Report Number
    2243471-2021-03625
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 4, 2021
    Report Date
    December 3, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 0

    AS THE RUN LOGS FOR THE ALLEGED RUNS WERE NOT PROVIDED, THE DATA COULD NOT BE REVIEWED TO DETERMINE THE CAUSE OF THE DISCREPANT RESULTS. THE INVALID INFLUENZA A RESULT GENERATED FROM RUN #2576, IN ADDITION TO THE POSITIVE INFLUENZA B RESULT, INDICATED A VERY HIGH LIKELIHOOD THAT THE RUN IS RELATED TO SBN-RDS-MOLECULAR LAB-2021-005. FURTHERMORE, THERE WAS NOT ENOUGH INFORMATION PROVIDED FOR THE OTHER THREE SAMPLES TO DETERMINE IF THEY MIGHT BE RELATED TO THE SBN OR WHETHER, THE DISCREPANCIES IS DUE TO OTHER FACTORS SUCH AS LOW TITER SAMPLES. ADDITIONALLY, THESE SAMPLES WERE RETESTED ON A DIFFERENT PLATFORM, WHICH COULD LEAD TO DISCREPANT RESULTS DUE TO INHERENT DIFFERENCES IN THE TECHNOLOGIES. (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 ALLEGED DISCREPANT RESULTS OF 4 PATIENT SAMPLES WHEN USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST ASSAY FOR USE ON THE COBAS® LIAT® SYSTEM INITIAL TESTS FOR THE 4 PATIENT SAMPLES WERE PERFORMED ON 3 DIFFERENT COBAS® LIAT® SYSTEMS AND GENERATED INFLUENZA B, POSITIVE, SARS-COV-2 & INFLUENZA A NEGATIVE. THE SAME 4 SAMPLES WERE REPEATED USING THE GENEXPERT CEPHEID AND THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULTS WERE REPORTED TO THE PATIENTS AND OR/ MEDICAL PERSONNEL TREATING THE PATIENTS. NO HARM OR INJURY IS ALLEGED. INVESTIGATION IS IN PROGRESS. PER THE FDA GUIDANCE FOUR (4) MDRS WILL BE FILED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639440 COBAS® LIAT® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown