BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NMIC-312

    MDR report key: 24132916 · Received January 21, 2026

    Report

    Report Number
    1119779-2026-00019
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 30, 2025
    Report Date
    February 23, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904490820
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS WITH PSEUDOMONAS AERUGINOSA, ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE WHEN USING PHOENIX PANEL NMIC-312 (CATALOG NUMBER 449082) BATCH NUMBER 5324466. THE CUSTOMER PROVIDED PHOENIX GENERATED LAB REPORTS SHOWING FAILED MIC RESULTS FOR THE INVESTIGATION. 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. UPON INVESTIGATION FROM AN ONSITE VISIT, IT WAS DISCOVERED THAT THE AP INSTRUMENT WAS CONTAMINATED. IT IS RECOMMENDED TO PERFORM ROUTINE DECONTAMINATION ON THE INSTRUMENTS AND ENVIRONMENT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR A PERFORMANCE ISSUE. 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.

    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, K023444, K023634, K023858, K033458, K042932, K060214, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K062945, K063486, K063573, K063811, K063824, K123404, K132674, K132909, K163637, K173252, K173523, K181665, AND K233986. 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 NMIC-312 AN UNSPECIFIED OF PATIENT AND QC ISOLATES HAD HIGH MICS FOR THE DRUGS ERTAPENEM OR MEROPENEM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE NMIC-312 AN UNSPECIFIED OF PATIENT AND QC ISOLATES HAD HIGH MICS FOR THE DRUGS ERTAPENEM OR MEROPENEM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200163 NMIC-312 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5324466 30382904490820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown