BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 24041757 · Received January 12, 2026

    Report

    Report Number
    1119779-2025-05555
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 6, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904490363
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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, K021954, K022172, K023273, K023301, K023568, K024152, K030091, K030677, K031306, K031679, K032131, K033784, K033889, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K082913, K131331, AND K14046. 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 PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECALIS) HAD A LOW MIC (FALSE SUSCEPTIBLE) RESULT FOR THE DRUG VANCOMYCIN. THE USER VERIFIED THE FINAL RESULT USING BIOFIRE ® FILMARRAY AND KIRBY BAUER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26233 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5091318 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1