BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 23006660 · Received September 9, 2025

    Report

    Report Number
    1119779-2025-04964
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 2, 2025
    Report Date
    September 24, 2025
    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

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-(B)(4) (CATALOG NUMBER 449289) BATCH NUMBER 5140674. THE CUSTOMER RETURNED AN ISOLATE AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER NOTED MISIDENTIFICATIONS OF HAEMOPHILUS PARAINFLUENZAE AS RODENTIBACTER PENUMOTROPICUS AND PROVIDENCIA STUARTII AS ESCHERICHIA COLI WHEN USING THE COMPLAINT BATCH. IT IS TO BE NOTED THAT BD DOES NOT HAVE ID CLAIMS FOR H. PARAINFLUENZAE. THE CUSTOMER RETURNED ISOLATE (A. FAECALIS 853596) WAS FOUND TO BE MIXED WITH STAPHYLOCOCCUS EPIDERMIDIS, A. FAECALIS WAS ISOLATED WITH A BRUKER MALDI BIOTYPER AND USED FOR INVESTIGATION TESTING. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE AND CUSTOMER RETURNED ISOLATES P. STUARTII BL-01, A. FAECALIS 853596 AND A. FAECALIS 457 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THIS COMPLAINT IS NOT CONFIRMED. 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. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT WOUND ISOLATE (ALCALIGENES FAECALIS) WAS MISIDENTIFIED AS MORAXELLA SPECIES. THE USER ALSO NOTED QC AND SURVEILLANCE FAILURES AS WELL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-(B)(4) A PATIENT WOUND ISOLATE (ALCALIGENES FAECALIS) WAS MISIDENTIFIED AS MORAXELLA SPECIES. THE USER ALSO NOTED QC AND SURVEILLANCE FAILURES AS WELL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836215 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5140674 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown