BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PCR CARTRIDGE

    MDR report key: 20581746 · Received October 31, 2024

    Report

    Report Number
    3007420875-2024-00112
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 2, 2024
    Report Date
    January 25, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    30382904375196
    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

    B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. D1: MEDICAL DEVICE BRAND NAME: BD PCR CARTRIDGE D2A: COMMON DEVICE NAME: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY D2B: MEDICAL DEVICE TYPE: OOI AND NJR D4. MEDICAL DEVICE LOT #: 4143963 D4. MEDICAL DEVICE EXPIRATION DATE: 10-JUN-2026 H4. DEVICE MANUFACTURE DATE: 22-MAY-2024 D.4 UDI#: (B)(6). 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. 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.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: QQX. E.1. INITIAL REPORTER ADDR 1: (B)(6). 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 PCR CARTRIDGE, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. 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. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066371 BD PCR CARTRIDGE THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4143963 30382904375196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown