BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 22044232 · Received May 19, 2025

    Report

    Report Number
    1119779-2025-00392
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    October 25, 2024
    Report Date
    May 16, 2025
    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
    WI, 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, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K181665, K173252, K190905, K163637, K173523, K033458, AND K123266. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC CEFUROXIME (CXM) AND CEFAZOLIN (CZ) WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBERS 4233342 AND 4248245. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES AND BINARY FILES FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE TWO COMPLAINT BATCHES WERE INOCULATED WITH CUSTOMER RETURNED AND IN HOUSE ISOLATES ESCHERICHIA COLI WD-1 THROUGH WD-7, CITROBACTER KOSERI WD-8, ESCHERICHIA COLI ENF 11071, CITROBACTER KOSERI ENF 12466 AND CITROBACTER KOSERI FR-6 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR CXM AND CZ MIC RESULTS. NEXT, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED AND IN HOUSE ISOLATES ESCHERICHIA COLI WD-1 THROUGH WD-7, CITROBACTER KOSERI WD-8, ESCHERICHIA COLI ENF11071, CITROBACTER KOSERI ENF 12466 AND CITROBACTER KOSERI FR-6 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR CXM AND CZ MIC RESULTS. FOR FURTHER INVESTIGATION, DISC DIFFUSION TESTING WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATES ESCHERICHIA COLI WD-1 THROUGH WD-7 AND CITROBACTER KOSERI WD-8. DISC DIFFUSION RESULTS SHOW MIC VALUES TO BE THE SAME RESULTS AS INTERNAL TESTING OF PHOENIX PANELS OR WITHIN ONE DILUTION OF THE EXPECTED RESULT. BD DOES NOT CONFIRM ON AN INTERMEDIATE (I) RESULT AS IT IS ONE DILUTION OFF FROM SENSITIVE (S) OR RESISTANT (R). PER CLSI M23(DEVELOPMENT OF IN VITRO SUSCEPTIBILITY TEST METHODS, BREAKPOINTS, AND QUALITY CONTROL PARAMETERS), THE DECISION TO REPORT INTERMEDIATE RESULTS IS BEST MADE BY EACH LABORATORY BASED ON INSTITUTION-SPECIFIC GUIDELINES. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. THE TWO BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. 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 HAD HIGH MICS FOR THE DRUG CEFUROXIME. THE USER NOTED THAT RESULTS FOR CEFUROXIME THAT WERE HIGH ARE BEING SUPPRESSED WHEN THE DRUG CEFAZOLIN IS SUSCEPTIBLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166242 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4248245 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown