BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COR¿ MX

    MDR report key: 22181467 · Received June 10, 2025

    Report

    Report Number
    1119779-2025-00563
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 24, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LSL
    UDI-DI
    00382904439897
    PMA / PMN Number
    K210585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS THE RESULT OF A REQUEST FOR INFORMATION FROM THE CUSTOMER. THE CUSTOMER WANTED TO CONFIRM THE RESULT ON THE MX USING THE VAGINAL PANEL ASSAY. A BD FIELD SERVICE ENGINEER WAS DISPATCHED TO REVIEW RUN FILES AND PERFORM HEALTH CHECK. THE SAMPLE WAS REPEATED AND THE RESULTS WERE CONFIRMED USING THE CUSTOMER'S BD MAX INSTRUMENT. THIS COMPLAINT IS AN UNCONFIRMED FAILURE OF THE BD COR MX. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. DHR REVIEW WAS CONDUCTED AND THERE WERE NO ABNORMALITIES RELATED TO THIS FAILURE MODE DURING MANUFACTURING ACCEPTANCE TESTING. SERVICE HISTORY REVIEW REVEALED THERE WAS ONE PREVIOUS COMPLAINT FOR THIS ISSUE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE.

    Additional Manufacturer Narrative · 0

    D2B. MKZ, OUY, QEP. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD COR MX INSTRUMENT THERE WAS A FALSE POSITIVE RESULT FOR ALL MM2 TARGETS ON THE COR VAGINAL PANEL ASSAY. CONFIRMATORY TESTING WAS PERFORMED ON BD MAX INSTRUMENT AND INDICATED THAT ONLY ONE TARGET WAS POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF BD COR MX INSTRUMENT THERE WAS A FALSE POSITIVE RESULT FOR ALL MM2 TARGETS ON THE COR VAGINAL PANEL ASSAY. CONFIRMATORY TESTING WAS PERFORMED ON BD MAX INSTRUMENT AND INDICATED THAT ONLY ONE TARGET WAS POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103047 BD COR¿ MX THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY LSL BECTON DICKINSON & CO. (SPARKS) 00382904439897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown