BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COR PX/MX

    MDR report key: 17282796 · Received July 7, 2023

    Report

    Report Number
    1119779-2023-00752
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 13, 2023
    Report Date
    September 23, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    QEP
    PMA / PMN Number
    K210585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD COR MX INSTRUMENT (CATALOG NUMBER 443989) HAD A "FALSE POSITIVE" RESULT ON CTGCTV2 ASSAY. CUSTOMER REPORTED THAT A PATIENT WAS POSITIVE FOR CT WITH CT SCORE OF 35.7 AND TV WITH CT SCORE OF 37.5. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, CRM0105 IS NOT REQUIRED BECAUSE THE COMPLAINT IS UNCONFIRMED AND DOES NOT ALLUDE TO ANY INSTRUMENT ISSUE. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT CRM0105 AND NO ADDITIONAL WORK ORDER WAS OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. RUN FILES AND LOG FILES WERE RETRIEVED FOR THE INSTRUMENT. CURVE ANALYSIS FOR ASCENSION (B)(6) SHOWS THAT THE SAMPLE WAS IN LANE BOTTOM 12 (B12) ON APS1. REVIEW OF THE ROX CURVE SHOWS THAT ALL CURVES EXCEPT B12 SHOWS SMOOTH AMPLIFICATION WHICH IS EXPECTED AS THE INTERNAL CONTROL FOR CTGCTV2 IS IN THE ROX CHANNEL. THE INTERNAL CONTROL CURVE FOR B12 IS EXPECTED TO AMPLIFY SMOOTHLY IF THE RESULTS WERE POSITIVE, BUT THE CURVES SHOW WEAK AMPLIFICATIONS. REVIEW OF CY5 CHANNEL CURVES (USED FOR TV) FOR B12 SHOWS THAT THERE IS A DROP AND RAISE IN THE ADC AND RAW CURVES, BUT AMPLIFICATION ON THE BACKGROUND CORRECTED CURVES. REVIEW OF FAM CHANNEL CURVES (FOR CT) FOR B12 SHOWS A DROP AND RAISE IN THE ADC AND RAW CURVES, BUT AMPLIFICATION ON BACKGROUND CORRECT CURVES. REVIEW OF VIC AND CY5.5 SHOWS SIMILAR BEHAVIOR AS WELL BUT THE BACKGROUND CORRECT CURVE DID NOT AMPLIFIED TO THE THRESHOLD OF BEING CALLED POSITIVE. SINCE ALL CHANNELS IN LANE B12 EXHIBIT THE SAME BEHAVIOR, IT IS CONCLUDED THAT A BUBBLE IS IN THE CARTRIDGE. CHANNEL B12 IS NORMALLY PROCESSED BY PIPETTOR #1 IN APS1. REVIEW OF OTHER LANES IN WHICH PIPETTOR #1 PROCESS (T12, T11, B11, ETC.) HAS SHOWN SMOOTH CURVES FOR AMPLIFICATION AND FLAT CURVES FOR NEGATIVE RESULTS. THIS SHOWS THAT PIPETTOR #1 IS NOT MAIN ISSUE. TEACH WAS ELIMINATED AS LANE TOP 12, BOTTOM 1, AND BOTTOM 10 EXHIBIT NORMAL BEHAVIOR AND IS NORMALLY THE TEACH POINT OF THE INSTRUMENT. SINCE NO ISSUES WERE NOTED WITH THE PIPETTORS, THE PRESSURE CONTROLLERS CAN BE ELIMINATED. REAGENT LOT CAN BE ELIMINATED AS THIS IS ONLY AFFECT ONE LANE AND NOT MULTIPLE LANES. POSSIBILITY IS DUE TO ONE BAD TIP DURING THAT PROCESS OR CUSTOMER WORKFLOW IN SAMPLE PREPARATION. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT IS UNCONFIRMED BY QUALITY ENGINEERING. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD COR PX/MX THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO THE PATIENT. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PATIENT WAS POSITIVE FOR CT (CT:35.7) AND TV (CT:37,5). ACCORDING TO THIS PATIENT IT IS IMPOSSIBLE FOR THIS TO BE TRUE, AND HAS TAKEN 3 SAMPLES AFTER THAT ARE ALL COMPLETELY NEGATIVE. ACCESSION NUMBER IS (B)(4), TESTED ON 13TH JUNE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD COR PX/MX THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. RESULTS WERE REPORTED TO THE PATIENT. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PATIENT WAS POSITIVE FOR CT (CT:35.7) AND TV (CT:37,5). ACCORDING TO THIS PATIENT IT IS IMPOSSIBLE FOR THIS TO BE TRUE, AND HAS TAKEN 3 SAMPLES AFTER THAT THAT ARE ALL COMPLETELY NEGATIVE. ACCESSION NUMBER IS (B)(6), TESTED ON 13TH JUNE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498463 BD COR PX/MX NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TR QEP BECTON DICKINSON & CO. (SPARKS) 443989

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown