BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

    MDR report key: 20577182 · Received October 31, 2024

    Report

    Report Number
    3007420875-2024-00107
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 3, 2024
    Report Date
    January 31, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    QOF
    UDI-DI
    00382904452155
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THERE IS AN INDICATION OF A BD PCR CARTRIDGES (REF. (B)(4)) ISSUE FOR THE LOT USED BY THE CUSTOMER BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR UNUSUAL CURVES PRESENTING AN UPWARD DRIFT IN THE CY5 CHANNEL WHEN USING THE BD PCR CARTRIDGES WITH THE BD MAX RVP ASSAY. ALTHOUGH THIS UPWARD DRIFT EXPLAINS THE POSITIVE AND VALID NEGATIVE RESULTS OBTAINED FOR THESE SAMPLES, THE CURVES DO NOT SUGGEST TRUE AMPLIFICATIONS. CARTRIDGES MAY CONTRIBUTE TO FLU A FALSE POSITIVE RESULTS (CY5 CHANNEL) AND NEGATIVE CONTROL FAILURE (RNASEP VALID RESULT; ROX CHANNEL), DUE TO BACKGROUND CORRECTION VARIABILITY. THE ROOT CAUSE FOR THE CY5 AND ROX CHANNEL FLUORESCENCE SIGNAL ISSUES ASSOCIATED WITH THE BD PCR CARTRIDGES LOT WAS IDENTIFIED DURING CORRECTIVE AND PREVENTIVE ACTION INVESTIGATION. A CHANGE IN THE ADHESIVE SUPPLIER BY BD¿S PCR CARTRIDGE LABEL SUPPLIERS WAS IDENTIFIED AS THE ROOT CAUSE FOR THE OBSERVED ISSUE. ACTIONS WERE TAKEN BOTH INTERNALLY AT BD AND EXTERNALLY WITH OUR SUPPLIERS TO PREVENT THE RECURRENCE OF THIS PRODUCT ISSUE. BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: 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

    REPORT 2 OF 4: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 2 OF 4: IT WAS REPORTED THAT DURING USE OF THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. WHEN THE SAMPLE WAS REPEATED, THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012212 BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE QOF GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4194293 00382904452155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown