BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 18478025 · Received January 9, 2024

    Report

    Report Number
    1119779-2023-01491
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 11, 2023
    Report Date
    May 1, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904481001
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). THE CUSTOMER REPORTED THAT MISSED IDS AND LAMPS ABOUT TO EXPIRE. THE FSE WAS DISPATCHED FOR THIS CASE. BASED FROM THE WORK ORDER, THE FSE SAVED SYSTEM DATA, SAVED SYSLOG, REPLACED UV LAMPS, QUALIFED AND TESTED INSTRUMENT AND THE RESULT IS OK. THE INSTRUMENT HAS BEEN RETURNED TO CUSTOMER FOR USE. 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. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE PMA/510K NUMBERS. THE INFORMATION FOR EACH ADDITIONAL PMA/510K IS AS FOLLOWS: G.5. PMA / 510(K)#: K020322, K020323, K040099, K131331 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WAS A SAMPLE MISIDENTIFICATION. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WAS A SAMPLE MISIDENTIFICATION. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597532 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