BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 23126455 · Received September 23, 2025

    Report

    Report Number
    1119779-2025-04969
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    July 7, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    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 OF ESCHERICHIA COLI AS SHIGELLA FLEXNERI WHEN USING PHOENIX PANEL NMIC/ID-307(CATALOG NUMBER 449292) BATCH NUMBER 5119633. THE CUSTOMER RETURNED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF S. FLEXNERI WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH WERE TESTED USING IN HOUSE AND CUSTOMER RETURNED ISOLATES ESCHERICHIA COLI 18187, E. COLI A25922 AND E. COLI 848104 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT A DIFFERENT BATCH WERE TESTED USING IN HOUSE AND CUSTOMER RETURNED ISOLATES ESCHERICHIA COLI 18187, E. COLI A25922 AND E. COLI 848104 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. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    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 URINE ISOLATE (ESCHERICHIA COLI ESBL) WAS MISIDENTIFIED AS SHIGELLA FLEXNERI. REPEAT TESTING WAS PERFORMED. THE USER ALSO NOTED QC AND SURVEILLANCE FAILURES AS WELL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT URINE ISOLATE (ESCHERICHIA COLI ESBL) WAS MISIDENTIFIED AS SHIGELLA FLEXNERI. REPEAT TESTING WAS PERFORMED. THE USER ALSO NOTED QC AND SURVEILLANCE FAILURES AS WELL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734059 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5119633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown