BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 22349617 · Received June 27, 2025

    Report

    Report Number
    1119779-2025-00732
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 26, 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
    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 ERTAPENEM (ETP) RESULTS WITH CITROBACTER FREUNDII WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5091300. THE CUSTOMER PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE CITROBACTER FREUNDII ENF 19115 TO OBSERVE FOR ETP MIC RESULTS. NEXT, RETENTION PANELS FROM THE COMPLAINT BATCH AND CONTROL PANELS WERE INOCULATED WITH IN HOUSE ISOLATE CITROBACTER FREUNDII ENF 19115 TO OBSERVE FOR ETP MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SATISFACTORY ETP MIC RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. 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. FOR FURTHER REVIEW, COMPLAINTS DUE TO THIS DEFECT 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. 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 (CITROBACTER FREUNDII) HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG ERTAPENEM. THE USER VERIFIED THE FINAL RESULT AS SUSCEPTIBLE TO ERTAPENEM USING E-TEST STRIP. 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 (CITROBACTER FREUNDII) HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG ERTAPENEM. THE USER VERIFIED THE FINAL RESULT AS SUSCEPTIBLE TO ERTAPENEM USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938903 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5091300 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown