BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 18746799 · Received February 21, 2024

    Report

    Report Number
    1119779-2024-00128
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 23, 2024
    Report Date
    May 2, 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
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDRESS: (B)(6). G5. MULTIPLE 510(K): 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A FAILURE FOR MISIDENTIFICATION OF RESULTS WAS REPORTED ON A PHOENIX 100 INSTRUMENT (P/N 448100, S/N (B)(6). THE CUSTOMER REPORTED THAT THERE WERE FAILURES IN THE IDENTIFICATION OF MICROORGANISMS. THE FSE WAS DISPATCHED FOR THIS CASE. BASED ON THE WORK ORDER SUMMARY, THE FSE PROPOSED THE EQUIPMENT PRE-INSTALLATIONS MUST FIRST BE ENSURED BEFORE MOVING THE EQUIPMENT IN THE SAME COUNTER NEAR THE BACTEC FX, PLACE A FILM ON HALF OF THE WINDOWS TO PREVENT SUN ENTRY AND INSTALL AIR CONDITIONING. THERE IS AN ELECTRICAL OUTLET IN THE LABORATORY WITH A NEUTRAL - GROUND VOLTAGE OF 1.23 VAC, PHASE - NEUTRAL 124.3 VAC AND PHASE - GROUND 125.1 VAC AND IT IS REQUESTED TO VERIFY THE PANEL OF THAT OUTLET IN ORDER TO BE ABLE TO DRAW A DERIVATION FOR THE EQUIPMENT. THEREFORE, THIS IS NOT CONFIRMED FAILURE OF 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. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THE INSTRUMENT FAILED TO CORRECTLY IDENTIFY ORGANISMS. 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, THE INSTRUMENT FAILED TO CORRECTLY IDENTIFY ORGANISMS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48310 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