BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 23770366 · Received December 10, 2025

    Report

    Report Number
    1119779-2025-05489
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 23, 2025
    Report Date
    January 22, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492923
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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)#: K020322, K022129, K023444, K023634, K023858, K024153, 031530, K031699, K031912, K032299, K032567, K032655, K032675, K033362, K033458, K033558, K033560, K041384, K042932, K052269, K060214, 060217, K060257, K060444, K060447, K061327, K061355, K061867, K062207, K062944, K063301, AND K06348. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D10. DEVICE AVAILABLE FOR EVAL- YES, D10. RETURNED TO MANUFACTURER ON 12-DEC-2025, H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC CEFTOLOZANE-TAZOBACTAM (CT) WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5266643. THE CUSTOMER RETURNED PANELS, ISOLATES, PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR INVESTIGATION. THE LAB REPORTS SHOW HIGH MIC RESULTS FOR CT WITH ESCHERICHIA COLI AND CITROBACTER BRAAKII WHEN USING THE COMPLAINT BATCH. THE THREE ISOLATES RECEIVED WERE C. BRAAKII 4054, E. COLI 1357 AND E. COLI 2641. THE BATCH HISTORY RECORD REVIEW FOR THE COMPLAINT BATCHES WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OR INSPECTION. FORMULATION, FILLING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS ARE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. TO INVESTIGATE, CUSTOMER RETURNED PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI 1357, E. COLI 2641 AND C. BRAAKII 4054 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR CT MIC RESULTS. NEXT, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE ALSO INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI 1357, E. COLI 2641 AND C. BRAAKII 4054 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR CT MIC RESULTS. THE CUSTOMER RETURNED AND CONTROL PANELS TESTED WITH CUSTOMER RETURNED ISOLATES E. COLI 1357 AND E. COLI 2641 RETURNED SUSCEPTIBLE CT ALONG WITH SUSCEPTIBLE MEM RESULTS. THE CUSTOMER RETURNED AND CONTROL PANELS TESTED WITH CUSTOMER RETURNED ISOLATE C. BRAAKII 4054 RETURNED SUSCEPTIBLE MIC RESULTS FOR MEM ALONG WITH RESISTANT MIC RESULTS FOR CT. BD R&D REVIEWED THE CUSTOMER'S RESULTS SIDE BY SIDE WITH THE RESULTS FROM BD'S INTERNAL COMPLAINT TESTING. IT WAS DETERMINED THROUGH REVIEW OF CUSTOMER RESULTS THAT ISOLATE # 1 (E. COLI ACCESSION # 8770) AND ISOLATE # 2 (C. BRAAKII 4054) LIKELY POSSESS AN AMPC RESISTANCE MECHANISM DUE TO RESISTANT RESULTS FOR CEFAZOLIN, CEFTAZIDIME, CEFTRIAXONE AND CEFOXITIN ALONG WITH SUSCEPTIBLE AND INTERMEDIATE RESULTS FOR CEFEPIME. IT IS TO BE NOTED THAT THE PRESENCE OF AMPC CAN CAUSE CT RESISTANCE BUT WOULD NOT IMPACT CARBAPENEMS. THEREFORE, ISOLATES #1 AND #2 WERE DETERMINED TO BE A STRAIN SPECIFIC FAILURE AND NOT INDICATIVE OF THE PHOENIX SYSTEM AS A WHOLE. ANALYSIS OF THE PHOENIX GROWTH PLOTS FOR ISOLATES # 3 (E. COLI 1357) AND ISOLATE # 4 (E. COLI 2641) INDICATES LOW LEVEL CONTAMINATION WHICH COULD BE ATTRIBUTED TO INTRODUCING MULTIPLE ORGANISM STRAINS INTO THE ID BROTH INOCULUM DURING THE COLONY PICKING PROCESS, BIOBURDEN WITHIN THE AP SYSTEM OR ENVIRONMENTAL ISSUES. FOR FURTHER REVIEW, COMPLAINTS DUE TO HIGH MIC FOR CT ACROSS THIS MATERIAL (#449292) WERE REVIEWED AND THERE ARE NO TRENDS ASSOCIATED WITH THIS DEFECT. AS NO 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD A HIGH MIC FOR THE DRUG CEFTOLOZANE/TAZOBACTAM (RESISTANT) WHILE THE DRUG MEROPENEM WAS SUSCEPTIBLE AND MINOCYCLINE WAS SUSCEPTIBLE. IN ADDITION, THE EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) MARKER WAS NOT FLAGGED. THE USER NOTED PERFORMING REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD A HIGH MIC FOR THE DRUG CEFTOLOZANE/TAZOBACTAM (RESISTANT) WHILE THE DRUG MEROPENEM WAS SUSCEPTIBLE AND MINOCYCLINE WAS SUSCEPTIBLE. IN ADDITION, THE EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) MARKER WAS NOT FLAGGED. THE USER NOTED PERFORMING REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211362 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5266643 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown