BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 19363497 · Received May 21, 2024

    Report

    Report Number
    1119779-2024-00397
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 3, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904481001
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DISCREPANCY IN IDENTIFICATION RESULTS BETWEEN PHOENIX 100 AND MALDI WAS REPORTED. THE CUSTOMER ADVISED THAT MALDI HAD IDENTIFIED A SAMPLE AS E. COLI, WHILE PHOENIX 100 HAD PRODUCED A DIFFERENT RESULT USING PANEL NMIC/ID 402, AND ANOTHER SAMPLE WAS IDENTIFIED BY MALDI AS MORGANELLA MORGANI, WHILE PHOENIX 100 HAD IDENTIFIED THIS AS LEMINORELLA GRIMONTII USING PANEL UNMIC/ID 403. BD APPLICATIONS COMMUNICATED WITH THE CUSTOMER THROUGH REMOTE ASSISTANCE TO CONFIRM THE CORRECT WORKFLOW WAS PERFORMED FOR THE PANEL PROCEDURE AND THE STARTER PLATES. NO ERRORS WERE REPORTED WITH THE INSTRUMENT. AN INVESTIGATION INTO THE ASSOCIATED REAGENTS WAS OPENED. NO SERVICE WAS PERFORMED UPON THE INSTRUMENT AND TESTING WAS REPEATED. AS NO FAILURE OF THE INSTRUMENT WAS IDENTIFIED, THIS IS AN UNCONFIRMED FAILURE OF THE PHOENIX 100. FURTHER INVESTIGATION WILL OCCUR FOR THE ASSOCIATED REAGENTS. THE ROOT CAUSE OF THE FAILURE IS NOT KNOWN. DEVICE HISTORY RECORD 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 AGAINST THE INSTRUMENT RELATED TO THIS FAILURE MODE. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    G5. PMA / 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM FREQUENT MISIDENTIFICATIONS OCCURRED WITH PATIENT SAMPLES. THE USER NOTED TWO SPECIFIC MISIDENTIFICATIONS, ONE ISOLATE WAS IDENTIFIED AS AN E. COLI, AND THE OTHER WAS IDENTIFIED AS MORGANELLA MORGANII. THE USER USED MALDI TO CORRECTLY IDENTIFY THE ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM FREQUENT MISIDENTIFICATIONS OCCURRED WITH PATIENT SAMPLES. THE USER NOTED TWO SPECIFIC MISIDENTIFICATIONS, ONE ISOLATE WAS IDENTIFIED AS AN E. COLI, AND THE OTHER WAS IDENTIFIED AS MORGANELLA MORGANII. THE USER USED MALDI TO CORRECTLY IDENTIFY THE ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156558 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