BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COR¿ MX

    MDR report key: 21691589 · Received March 25, 2025

    Report

    Report Number
    1119779-2025-00215
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 5, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A. DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA, TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM, NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TRANSMITTED INFECTIONS. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT ALLEGES THE BD COR MX HAD A SAMPLE THAT RECEIVED A FALSE POSITIVE RESULT FOR TV AND UNRESOLVED FOR CT/GC. IT IS THE CUSTOMER'S PROTOCOL TO REPEAT UNRESOLVED RESULTS ON THE BD MAX, WHERE A NEGATIVE WAS RECEIVED FOR ALL TESTS ON THIS SPECIMEN. NO INSTRUMENT ISSUES WERE DETECTED; THE UNIT IS FUNCTIONING CORRECTLY. A CASE HAS BEEN CREATED TO INVESTIGATE THE REAGENTS USED DURING THIS TESTING. THIS COMPLAINT IS AN UNCONFIRMED INSTRUMENT FAILURE. 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 IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FOR MANUFACTURING DUE TO SERVICE REPAIRS/PMS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BD COR MX INSTRUMENT, THERE WAS 1 FALSE POSITIVE RESULT FOR THE TRICHOMONAS VAGINALIS PANEL. CONFIRMATORY TESTING WAS PERFORMED ON THE BD MAX, WHERE THE RESULT WAS NEGATIVE. AFTER OBSERVING THE BD COR GRAPHS, THE CUSTOMER DISCOVERED THAT THE SAMPLE HAD JUST CROSSED THE THRESHOLD TO BE CALLED POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BD COR MX INSTRUMENT, THERE WAS 1 FALSE POSITIVE RESULT FOR THE TRICHOMONAS VAGINALIS PANEL. CONFIRMATORY TESTING WAS PERFORMED ON THE BD MAX, WHERE THE RESULT WAS NEGATIVE. AFTER OBSERVING THE BD COR GRAPHS, THE CUSTOMER DISCOVERED THAT THE SAMPLE HAD JUST CROSSED THE THRESHOLD TO BE CALLED POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132331 BD COR¿ MX DNA-REAGENTS, NEISSERIA LSL BECTON DICKINSON & CO. (SPARKS) 00382904439897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown