BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 18383741 · Received December 22, 2023

    Report

    Report Number
    1119779-2023-01417
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 30, 2023
    Report Date
    February 27, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904481001
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "A FAILURE FOR MIS-IDENTIFICATION OF RESULTS WAS REPORTED ON A PHOENIX 100 INSTRUMENT (P/N 448100, S/N (B)(6)). A CUSTOMER REPORTED THERE IS IDENTIFICATION PROBLEM. REMOTE ASSISTANCE PROVIDED TO THE CUSTOMER. "SOURCE ADJUSTMENT", "UV ADJUSTMENT" AND "NORMALIZER CVS" WERE CARRIED OUT. LIGHT SOURCE FAILURE OF RINGS A AND B WAS FOUND. THE ROOT CAUSE IS LIGHT SOURCE RINGS A AND B FAILURE. THE USER IS INFORMED AND IT IS RECOMMENDED FOR THE MOMENT TO USE ONLY C AND D RINGS. THIS IS CONFIRMED FAILURE OF A BD PRODUCT. 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 FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW WAS COMPLETED AND REVEALED NO FURTHER CASES RELATED TO THIS FAILURE MODE, OUTSIDE OT THE ONE ALREADY DESCRIBED ABOVE. QUALITY WILL CONTINUE TO MONITOR THE RESULTS COMPLAINTS FOR PHOENIX 100 INSTRUMENTS. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT."

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6) G.5. PMA / 510(K)#: THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K020321, K020322, K020323, K040099, K131331 H3. 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

    IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WERE ISSUES WITH IDENTIFICATION OF PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WERE ISSUES WITH IDENTIFICATION OF PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570826 BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 00382904481001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown