BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 19374458 · Received May 22, 2024

    Report

    Report Number
    1119779-2024-00398
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 28, 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 : CUSTOMER REPORTED INCOMPATIBILITY IN TEST RESULTS IN A PHOENIX 100 INSTRUMENT. BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE. FSE PERFORMED CORRECTIVE MAINTENANCE AND UPDATED PUD TO VERSION 7.31A. ISSUE RESOLVED. AS NO RETURNS WERE RECEIVED TO CONFIRM THE FAILURE MODE, THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. 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 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

    E1: INITIAL REPORTER PHONE #: (B)(6). G4: 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 AN UNSPECIFIED NUMBER OF PATIENT MIC RESULTS WERE INCONSISTENT WITH WHAT THE USER EXPECTED. 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 PATIENT MIC RESULTS WERE INCONSISTENT WITH WHAT THE USER EXPECTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788949 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