BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

    MDR report key: 20620270 · Received November 6, 2024

    Report

    Report Number
    3007420875-2024-00114
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 11, 2024
    Report Date
    December 13, 2024
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL MEDICAL DEVICE TYPES: QQX. E1: INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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. THE ROOT CAUSE FOR THE CY5 SIGNAL DRIFT ISSUE ASSOCIATED WITH THE BD PCR CARTRIDGES LOT WAS NOT IDENTIFIED BUT A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO IDENTIFY ROOT CAUSE. ALTHOUGH THE ISSUE WAS NOT REPRODUCED WHEN TESTING RETAIN CARTRIDGE MATERIAL, BD CONFIRMS THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    REPORT 1 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. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 1 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. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133118 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