BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PCR CARTRIDGE

    MDR report key: 20981167 · Received December 19, 2024

    Report

    Report Number
    3007420875-2024-00211
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 27, 2024
    Report Date
    January 25, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    PMA / PMN Number
    K111860
    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. THE ROOT CAUSE FOR THE CY5 SIGNAL DRIFT ISSUE 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

    IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE FLU A PATIENT RESULTS WERE OBTAINED. THERE WERE NO REPORTS OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE FLU A PATIENT RESULTS WERE OBTAINED. THERE WERE NO REPORTS OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099468 BD PCR CARTRIDGE THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4143963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown