BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 16088640 · Received January 3, 2023

    Report

    Report Number
    2243471-2023-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 27, 2023
    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

    THE MOST LIKELY CAUSE FOR THE DISCREPANCY OBSERVED IS DUE TO THE SAMPLES HAVING A LOW VIRAL LOAD. BOTH POSITIVE TARGETS WERE IDENTIFIED TO BE AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY. NOTE THAT SAMPLES NEAR OR BELOW THE LOD OF THE TEST MAY GENERATE WAVERING RESULTS. OF NOTE, THE CUSTOMER COLLECTED NASOPHARYNGEAL SAMPLES USING UTM MEDIA BUT NO ADDITIONAL INFORMATION WAS PROVIDED TO DETERMINE IF THIS IS ON-LABEL. THE ASSAY METHOD SHEET RECOMMENDATION IS TO COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP USING 3 ML OF VIRAL TRANSPORT MEDIA ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND STANDARD COLLECTION TECHNIQUE. VALIDATED COLLECTION MEDIA KITS FOR EACH SPECIMEN TYPE CAN BE FOUND IN THE METHOD SHEET. COLLECTION KITS THAT ARE NOT RECOMMENDED IN THE METHOD SHEET COULD HAVE A DIFFERENT CHEMICAL COMPOSITION AND AFFECT THE PERFORMANCE OF THE ASSAY. ALSO, MANY STRONG POSITIVE INFLUENZA A RESULTS WERE IDENTIFIED IN THE DATA DURING THE SAME TIMEFRAME OF THIS ALLEGED SAMPLE RUN, CROSS-CONTAMINATION DURING PRE-ANALYTICAL ACTIVITY COULD BE A POSSIBILITY. THROUGHOUT THE DATA ANALYSIS AND INVESTIGATION, A SYSTEMATIC ISSUE WAS NOT OBSERVED AND A PRODUCT PROBLEM WAS NOT FOUND. CHANGED DEVICE CODE TO NON REPRODUCIBLE RESULTS.

    Additional Manufacturer Narrative · 0

    AS THE INVESTIGATION IS STILL ONGOING, A SUPPLEMENTAL REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION.

    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 THE UNITED STATES ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED POSITIVE RESULTS FOR INFLUENZA A AND B. THE SAME SAMPLE WAS RETESTED ON TWO DIFFERENT PLATFORMS ( DETAILS UNKNOWN) WHICH YIELDED NEGATIVE RESULTS. THE NEGATIVE RESULTS WERE REPORTED. NO HARM WAS ALLEGED. AN INVESTIGATION IS BEING CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 1 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523439 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20801X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown