BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ RESPIRATORY VIRAL PANEL

    MDR report key: 24605267 · Received March 16, 2026

    Report

    Report Number
    3007420875-2026-00053
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 9, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    QOF
    UDI-DI
    00382904453732
    PMA / PMN Number
    K230956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: QQX. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE NEGATIVE INFLUENZA A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEAT TESTED AND REMAINED INFLUENZA A NEGATIVE. SAMPLE WAS THEN TESTED ON FILMARRAY, WHICH IDENTIFIED THE SAMPLE AS INFLUENZA A POSITIVE. INFLUENZA A TYPING LDT WAS ALSO PERFORMED ON RESIDUAL SAMPLE AND THE RESULT WAS INFLUENZA A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667628 BD MAX¿ RESPIRATORY VIRAL PANEL MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT QOF GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5044778 00382904453732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown