BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 18614551 · Received January 31, 2024

    Report

    Report Number
    1119779-2024-00056
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 5, 2024
    Report Date
    May 20, 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
    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 A FALSE RESISTANCE ISSUE WITH THE INSTRUMENT. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR INVESTIGATION. THE FSE VERIFIED THAT THE TIPS USED ARE NOT ELONGATED, THUS POTENTIALLY CAUSING CONTAMINATION THROUGH THE PIPETTE THAT TOUCHES THE TUBE AT THE TIME OF TRANSFER. THE FSE CARRIED OUT THE PANEL PREPARATION PROCESS VERY CAREFULLY TO AVOID CONTAMINATION AND PERFORM SANITIZATION ON THE PIPETTE. THE FSE HAS VERIFIED THAT THE FALSE RESISTANCE ISSUE HAS NOT OCCURRED. THIS IS NOT TRUE FAILURE OF BD INSTRUMENT. THE COMPLAINT IS UNCONFIRMED. 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. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED BECAUSE OF THIS COMPLAINT. 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). THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 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 DURING USE OF THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THERE WAS FALSE RESISTANCE IN PATIENT RESULTS. THE RESULTS WERE VERIFIED BY MANUAL METHODOLOGY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM THERE WAS FALSE RESISTANCE IN PATIENT RESULTS. THE RESULTS WERE VERIFIED BY MANUAL METHODOLOGY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261904 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