BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PCR CARTRIDGE

    MDR report key: 21179185 · Received January 17, 2025

    Report

    Report Number
    3007420875-2024-00241
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    November 21, 2024
    Report Date
    April 29, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    30382904375196
    PMA / PMN Number
    K111860
    Removal / Correction Number
    Z-1004-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NJR. 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: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING BD PCR CARTRIDGES (REF. 437519) LOT 4185634, 4149768, 4191581 AND 4268747 ALONG WITH BD MAX EXK DNA-1 ASSAY (REF. 442817) WAS PERFORMED BY REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED SUSPECTING FALSE POSITIVE RESULTS ON EIGHT SAMPLES WHEN USING THEIR IN-HOUSE DEVELOPED TICK ASSAY. CUSTOMER PROVIDED TWELVE RUNS AND DATABASE FORM BD MAX INSTRUMENT CT3345 FOR INVESTIGATION. ANALYSIS SHOWED THAT ALL SAMPLES TARGETED IN THE COMPLAINT TEXT - RUN 129; POSITION A9, 131; A5, 135; A10, 149; B3, 152; B4, 160; A1 AND A4, AND 161; A8 - ARE SHOWING AN AMPLIFICATION CURVE IN THE ROX CHANNEL. THE EMURWL TARGET (ROX CHANNEL) CURVE¿S APPEARANCE DOES NOT SUGGEST A TRUE POSITIVE RESULT. THE BD PCR CARTRIDGES (REF. 437519) LOTS USED BY THE CUSTOMERS HAVE BEEN IDENTIFIED AS POTENTIALLY DEPICTING UNUSUAL CURVES PRESENTING AN UPWARD DRIFT. THE ROOT CAUSE FOR THE SIGNAL DRIFT ISSUE ASSOCIATED WITH THE BD PCR CARTRIDGES LOTS 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    REPORT 7 OF 8: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON MAX AND WAS FLU A NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 7 OF 9: IT WAS REPORTED THAT DURING USE OF THE BD PCR CARTRIDGE ON BD MAX INSTRUMENT, A FALSE POSITIVE FLU A PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED ON MAX AND WAS FLU A NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145545 BD PCR CARTRIDGE THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4191581 30382904375196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown