BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 18393619 · Received December 26, 2023

    Report

    Report Number
    1119779-2023-01433
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    December 4, 2023
    Report Date
    February 12, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A RESULTS FAILURE WAS REPORTED ON A PHOENIX 100 INSTRUMENT. THE CUSTOMER REPORTED FALSE RESISTANCE ISSUES WITH THEIR CARBAPENEM, VANCOMYCIN AND TEICOPLANIN DRUGS. TECHNICAL SERVICE WALKED THROUGH THE CUSTOMERS PREPARATION PROCESS AND DETERMINED THERE WAS AN ISSUE WITH CUSTOMER WORKFLOW. FEEDBACK WAS PROVIDED TO THE CUSTOMER. THE ROOT CAUSE OF THE FAILURE IS NOT KNOWN. THIS IS AN UNCONFIRMED 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 FOR THIS INSTRUMENT WAS REVIEWED AND REVEALED NO PREVIOUS COMPLAINTS RELATED TO THIS FAILURE MODE. COMPLAINTS FOR RESULTS ARE WITHIN STATISTICAL CONTROL FOR THE MONTH OF DECEMBER 2023. THE UPPER CONTROL LIMIT WAS NOT BREACHED. 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

    E.1: INITIAL REPORTER PHONE: (B)(6). E.1: INITIAL REPORTER ADDRESS: (B)(6). G.5: THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM DISCREPANT RESULTS WERE OBTAINED FOR SENSITIVITY TESTS FOR CARBAPENEMS, VANCOMYCIN AND TEICOPLANIN. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM DISCREPANT RESULTS WERE OBTAINED FOR SENSITIVITY TESTS FOR CARBAPENEMS, VANCOMYCIN AND TEICOPLANIN. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263150 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