BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 20389562 · Received October 7, 2024

    Report

    Report Number
    1119779-2024-00737
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 9, 2024
    Report Date
    December 3, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904481001
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTED FALSE RESISTANCE ISSUE IN THE RESULTS IN A PHOENIX 100 INSTRUMENT (P/N 448100, S/N (B)(6)). CUSTOMER SAID THAT THERE WAS VARIATION IN SENSITIVITY OF SOME DRUGS IN THE GRAM POSITIVE AND NEGATIVE PANEL. HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY FURTHER DETAILS. THE FIELD SERVICE ENGINEER (FSE) SAID THAT ALL THE TESTS WERE CONFIRMED WITH A MANUAL ANTIBIOGRAM. THE CUSTOMER WAS ADVISED TO CHECK FOR POSSIBLE CONTAMINATION, AS THIS ERROR IS USUALLY RELATED TO THIS. THE COMPLAINT IS UNCONFIRMED. 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. THE SERVICE HISTORY REVIEW WAS COMPLETED AND REVEALED NO FURTHER CASES RELATED TO THIS FAILURE MODE. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020321, K020322, K020323, K040099, AND 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 AN UNSPECIFIED NUMBER OF PATIENTS HAD VARIATIONS IN MIC RESULTS FOR BOTH GRAM NEGATIVE AND GRAM-POSITIVE ISOLATES. THE USER NOTED THAT ALL OF THE ISOLATES WERE CONFIRMED WITH A MANUAL ANTIBIOGRAM. THE USER WAS ALSO ADVISED TO CHECK FOR POSSIBLE CONTAMINATION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENTS HAD VARIATIONS IN MIC RESULTS FOR BOTH GRAM NEGATIVE AND GRAM-POSITIVE ISOLATES. THE USER NOTED THAT ALL OF THE ISOLATES WERE CONFIRMED WITH A MANUAL ANTIBIOGRAM. THE USER WAS ALSO ADVISED TO CHECK FOR POSSIBLE CONTAMINATION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542153 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