BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 23828894 · Received December 17, 2025

    Report

    Report Number
    1119779-2025-05502
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 6, 2025
    Report Date
    February 23, 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
    TX, 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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR CEFTAZIDIME/AVIBACTAM (CZA) AND CARBAPENEMS WHEN USING PANEL PHOENIX NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5254642. THE CUSTOMER RETURNED AN ISOLATE AND PHOENIX GENERATED LAB REPORTS WITH MIC RESULTS FOR ESCHERICHIA COLI FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS REVIEWED, AND NO CURRENT TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. HISTORICAL TRENDING WAS REVIEWED AND THERE WERE NO TRENDS FOR HIGH MIC RESULTS FOR PANEL SKU 449292. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI (B)(6) TO OBSERVE FOR CZA, ERTAPENEM AND MEROPENEM MIC RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI (B)(6) TO OBSERVE FOR CZA, ERTAPENEM AND MEROPENEM MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SUSCEPTIBLE CZA AND MEROPENEM MIC AND SIR RESULTS FOR THEIR INOCULATED ISOLATES, AND INTERMEDIATE ERTAPENEM MIC AND SIR RESULTS. BD DOES NOT CONFIRM ON AN INTERMEDIATE (I) RESULT, AS IT IS ONE DILUTION OFF FROM SENSITIVE (S) OR RESISTANT (R). THEREFORE, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. AS NO COMPLAINT TREND HAS BEEN IDENTIFIED, NO ACTIONS ARE INDICATED 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 BLOOD ISOLATE (ESCHERICHIA COLI) HAD A RESISTANT RESULT FOR THE DRUGS CEFTAZIDIME/AVIBACTAM AND ERTAPENEM WHILE THE DRUG MEROPENEM WAS SENSITIVE. CONVERSELY, THE USER NOTED THAT THE E-TEST RESULTS WERE SENSITIVE FOR CEFTAZIDIME/AVIBACTAM AND ERTAPENEM DURING REPEAT TESTING. A REFERENCE LABORATORY WAS USED GIVING SENSITIVE RESULTS AND THE CARBA-R PCR RESULT SHOWING ALL CARBAPENEMASES "NOT DETECTED." THE USER STATED, "THE PATIENT WAS TREATED WITH UNNECESSARY BROAD-SPECTRUM ANTIBIOTICS (CEFIDEROCOL AND ERAVACYCLINE) DUE TO FALSE RESISTANT CEFTAZIDIME AND AVIBACTAM RESULT REPORTED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT BLOOD ISOLATE (ESCHERICHIA COLI) HAD A RESISTANT RESULT FOR THE DRUGS CEFTAZIDIME/AVIBACTAM AND ERTAPENEM WHILE THE DRUG MEROPENEM WAS SENSITIVE. CONVERSELY, THE USER NOTED THAT THE E-TEST RESULTS WERE SENSITIVE FOR CEFTAZIDIME/AVIBACTAM AND ERTAPENEM DURING REPEAT TESTING. A REFERENCE LABORATORY WAS USED GIVING SENSITIVE RESULTS AND THE CARBA-R PCR RESULT SHOWING ALL CARBAPENEMASES "NOT DETECTED.". THE USER STATED, "THE PATIENT WAS TREATED WITH UNNECESSARY BROAD-SPECTRUM ANTIBIOTICS (CEFIDEROCOL AND ERAVACYCLINE) DUE TO FALSE RESISTANT CEFTAZIDIME AND AVIBACTAM RESULT REPORTED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335812 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5254642 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown