BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 23609704 · Received November 20, 2025

    Report

    Report Number
    1119779-2025-05448
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 20, 2025
    Report Date
    March 31, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR IMIPENEM (IPM) AND ERTAPENEM (ETP) WHEN USING PANEL PHOENIX NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 5189220. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS WITH RESULTS WITH ESCHERICHIA COLI FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS ANALYZED, 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 449289. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES ESCHERICHIA COLI A25922 AND ESCHERICHIA COLI 11002 TO OBSERVE FOR IPM AND ETP MIC RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES ESCHERICHIA COLI A25922 AND ESCHERICHIA COLI 11002 TO OBSERVE FOR IPM AND ETP MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SATISFACTORY SUSCEPTIBLE IPM AND ETP SIR AND MIC RESULTS, THEREFORE THIS COMPLAINT IS NOT CONFIRMED. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    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)#: 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 PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE FROM A URINE CULTURE (ESCHERICHIA COLI) HAD HIGH MICS FOR THE CARBAPENEM DRUG CLASS, THE USER ALSO NOTED PERFORMING REPEAT TESTING. THE USER VERIFIED THE FINAL RESULT USING A REFERENCE LABORATORY. THE USER IS UNSURE OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE FROM A URINE CULTURE (ESCHERICHIA COLI) HAD HIGH MICS FOR THE CARBAPENEM DRUG CLASS, THE USER ALSO NOTED PERFORMING REPEAT TESTING. THE USER VERIFIED THE FINAL RESULT USING A REFERENCE LABORATORY. THE USER IS UNSURE OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111233 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5189220 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown