BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC ID- 476

    MDR report key: 23632773 · Received November 24, 2025

    Report

    Report Number
    1119779-2025-05452
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 2, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904495114
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B1. INITIAL REPORTER PHONE #: (B)(6). 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 OF ESCHERICHIA COLI AS KLEBSIELLA PNEUMONIAE WHEN USING PHOENIX PANEL NMIC/ID-476 (CATALOG NUMBER 449511) BATCH NUMBER 5070760. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF K. PNEUMONIAE WHEN USING THE COMPLAINT BATCH. 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 E. COLI A25922, E. COLI 18187 AND E. COLI 11421 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. 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 PANEL PHOENIX NMIC ID- 476 A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE USER VERIFIED THE FINAL RESULT USING A FILMARRAY SEPSIS MOLECULAR PANEL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC ID- 476 A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE USER VERIFIED THE FINAL RESULT USING A FILMARRAY SEPSIS MOLECULAR PANEL. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467435 PANEL PHOENIX NMIC ID- 476 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5070760 00382904495114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown