BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-481

    MDR report key: 23809353 · Received December 15, 2025

    Report

    Report Number
    1119779-2025-05497
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 2, 2025
    Report Date
    February 11, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904495176
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-481 (CATALOG NUMBER 449517) BATCH NUMBER 5211478. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS SHOWING K. PNEUMONIAE IDENTIFICATIONS FOR THE INVESTIGATION. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATES K. PNEUMONIAE 10997, K. PNEUMONIAE 11001 AND K. PNEUMONIAE 16438 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.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PANEL PHOENIX NMIC/ID-481 A PATIENT URINE ISOLATE (ENTEROBACTER CLOACAE) WAS MISIDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE USER VERIFIED THE FINAL RESULT USING GENETIC TESTING. IT IS ALSO TO BE NOTED THAT THE PHYSICIAN NOTICED DISCREPANCIES IN RESULTS FOR THE SAME SPECIMEN AND CONTACTED THE MICROBIOLOGY LAB. THEREFORE, TREATMENT WAS LIKELY NOT ADMINISTERED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-481 A PATIENT URINE ISOLATE (ENTEROBACTER CLOACAE) WAS MISIDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE USER VERIFIED THE FINAL RESULT USING GENETIC TESTING. IT IS ALSO TO BE NOTED THAT THE PHYSICIAN NOTICED DISCREPANCIES IN RESULTS FOR THE SAME SPECIMEN AND CONTACTED THE MICROBIOLOGY LAB. THEREFORE, TREATMENT WAS LIKELY NOT ADMINISTERED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283456 PANEL PHOENIX NMIC/ID-481 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5211478 00382904495176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown