BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 23073644 · Received September 17, 2025

    Report

    Report Number
    1119779-2025-04981
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 20, 2025
    Report Date
    January 14, 2026
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS WITH CEFEPIME (FEP) AND LOW MIC RESULTS FOR CEFTAZIDIME (CAZ) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 5099033. THE CUSTOMER RETURNED PANELS, ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. CUSTOMER RETURNED ISOLATE 08-25-223-00323 WAS NOT A PURE CULTURE AND WAS NOT USED FOR INVESTIGATION TESTING. TO INVESTIGATE, RETENTION AND CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH THE THREE-CUSTOMER RETURNED P. AERUGINOSA ISOLATES TO OBSERVE FOR FEP AND CAZ MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH THE THREE-CUSTOMER RETURNED P. AERUGINOSA ISOLATES TO OBSERVE FOR FEP AND CAZ MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SUSCEPTIBLE MIC RESULTS FOR CAZ. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA 00537(2) AND P. AERUGINOSA 0312(3) RETURNED SUSCEPTIBLE AND INTERMEDIATE MIC RESULTS. DISK DIFFUSION WAS PERFORMED ON THE THREE-CUSTOMER RETURNED P. AERUGINOSA ISOLATES, AND THE RESULTS SHOW ALL THREE ISOLATES WERE SUSCEPTIBLE TO BOTH FEP AND CAZ. THIS COMPLAINT IS CONFIRMED FOR HIGH MIC FEP WITH P. AERUGINOSA; BUT NOT CONFIRMED FOR LOW MIC RESULTS FOR CEFTAZIDIME (CAZ) WITH PSEUDOMONAS AERUGINOSA. 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 (HIGH MIC FEP AND LOW MIC CAZ). FOR FURTHER REVIEW, COMPLAINTS FOR THIS DEFECT ACROSS THIS MATERIAL (#449289) WERE REVIEWED AND THERE ARE NO TRENDS ASSOCIATED WITH THESE DEFECTS (HIGH MIC FEP AND LOW MIC CAZ). AS NO COMPLAINT TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME PER BD PROCEDURES. 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. 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 ISOLATE (PSEUDOMONAS AERUGINOSA) HAD AN ABNORMAL MIC PATTERN FOR THE DRUGS CEFEPIME AS RESISTANT AND CEFTAZIDIME AS SENSITIVE. THE USER NOTED THAT THE PANEL MIC RESULTS FOR CEFTAZIDIME AS 8 WHILE CEFEPIME WAS 16. THE REFERENCE LABORATORY TESTING RESULTS USING BROTH DILUTION WERE CEFTAZIDIME AS 8 AND CEFEPIME AS 8, NO ERRONEOUS RESULTS WERE REPORTED DUE TO THIS CONFIRMATION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (PSEUDOMONAS AERUGINOSA) HAD AN ABNORMAL MIC PATTERN FOR THE DRUGS CEFEPIME AS RESISTANT AND CEFTAZIDIME AS SENSITIVE. THE USER NOTED THAT THE PANEL MIC RESULTS FOR CEFTAZIDIME AS 8 WHILE CEFEPIME WAS 16. THE REFERENCE LABORATORY TESTING RESULTS USING BROTH DILUTION WERE CEFTAZIDIME AS 8 AND CEFEPIME AS 8, NO ERRONEOUS RESULTS WERE REPORTED DUE TO THIS CONFIRMATION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635406 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5099033 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown