BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 13931751 · Received March 28, 2022

    Report

    Report Number
    2243471-2022-00327
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    February 27, 2022
    Report Date
    March 28, 2022
    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

    AS DATA WAS NOT PROVIDED, AN IN-DEPTH ANALYSIS COULD NOT BE PERFORMED. THE SENSITIVITY OF THE COMPETITOR TEST IS NOT KNOWN AND, THEREFORE, IT CANNOT BE DETERMINED IF THESE SAMPLES MAY HAVE BEEN NEAR THE LOD FOR THAT ASSAY. ADDITIONALLY, DIFFERENT ASSAYS USE DIFFERENT ALGORITHMS AND MAY ALSO TARGET DIFFERENT REGIONS OF THE VIRAL DNA. AS SUCH, RESULTS WITH ONE ASSAY MAY NOT BE REPRODUCIBLE WITH A DIFFERENT ASSAY. IN ADDITION, THE SAMPLE WAS COLLECTED USING VTM CATALOG NUMBER 102807, WHICH IS AN OFF-LABEL COLLECTION KIT. THE METHOD SHEET RECOMMENDS TO COLLECT SPECIMENS 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. A PRODUCT QUALITY ISSUE WAS NOT IDENTIFIED. DUE TO A LACK OF DATA AND INFORMATION, ADDITIONAL CONCLUSIONS CANNOT BE PROVIDED. (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 THE US 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 A POSITIVE RESULT FOR SARS-COV-2 AND A NEGATIVE RESULT FOR BOTH INFLUENZA A AND B. THE SAME SAMPLE WAS RETESTED 10 HOURS LATER ON A DIFFERENT DEVICE WHICH YIELDED NEGATIVE RESULTS. A NEW SAMPLE WAS COLLECTED AND TESTED ON A DIFFERENT DEVICE WHICH ALSO YIELDED NEGATIVE RESULTS. IT IS UNKNOWN WHICH ASSAY WAS USED FOR THE RETEST AND TEST OF THE RECOLLECTED SAMPLE. IT IS UNKNOWN IF HARM IS ALLEGED. AN INVESTIGATION WAS 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
    33162 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10920Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown