BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC ID- 476

    MDR report key: 24640117 · Received March 19, 2026

    Report

    Report Number
    1119779-2026-00440
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 18, 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
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. INITIAL REPORTER FACILITY NAME: (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 ACINETOBACTER BAUMANNII WHEN USING PHOENIX PANEL NMIC/ID-476 (CATALOG NUMBER 449511) BATCH NUMBER 5237356. DEVICE/BATCH HISTORY REVIEW: 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. INVESTIGATIONAL TESTING: TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE A. BAUMANNII 15748 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. CONCLUSION/OUTCOME: THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC ID- 476 A PATIENT ISOLATE (ACINETOBACTER BAUMANNII) WAS MISIDENTIFIED AS NEISSERIA ANIMALORIS. THE USER VERIFIED THE FINAL RESULT USING BACTERIAL CULTURE AND STATED, "THE PANEL INDICATED NON-FERMENTING BACILLUS (NFB), A RESULT CONSISTENT WITH ACINETOBACTER BAUMANNII, WHICH COINCIDES WITH THE FINDING OF THE PATIENT'S OTHER BLOOD CULTURE." 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 (ACINETOBACTER BAUMANNII) WAS MISIDENTIFIED AS NEISSERIA ANIMALORIS. THE USER VERIFIED THE FINAL RESULT USING BACTERIAL CULTURE AND STATED, "THE PANEL INDICATED NON-FERMENTING BACILLUS (NFB), A RESULT CONSISTENT WITH ACINETOBACTER BAUMANNII, WHICH COINCIDES WITH THE FINDING OF THE PATIENT'S OTHER BLOOD CULTURE." NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545023 PANEL PHOENIX NMIC ID- 476 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5237356 00382904495114

    Patients

    Seq Age Sex Outcome Treatment
    1