BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 23006664 · Received September 9, 2025

    Report

    Report Number
    1119779-2025-04968
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    May 18, 2025
    Report Date
    February 11, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION AND NO ID RESULTS WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 5042879. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. WATERS ADVANCED DIAGNOSTICS (FORMERLY BD DIAGNOSTIC SOLUTIONS) WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE AND QC ISOLATES SERRATIA MARCESCENS 17323, PROTEUS MIRABILIS A29906 AND ESCHERICHIA COLI 11002 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA /510(K)#: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, K033458 AND K123266. 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¿ NMIC/ID-307 A PATIENT ISOLATE (PROTEUS MIRABILIS) WAS MISIDENTIFIED AS MORGANELLA MORGANII. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 4 OF 4.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (PROTEUS MIRABILIS) WAS MISIDENTIFIED AS MORGANELLA MORGANII. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2803092 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5042879 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown