BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-485

    MDR report key: 23619218 · Received November 21, 2025

    Report

    Report Number
    1119779-2025-05449
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 21, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904495268
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6). A VALID LOT NUMBER WAS NOT REPORTED; HOWEVER, A POTENTIAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THAT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #:1051750. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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-485 A PATIENT ISOLATE (KLEBSIELLA PNEUMONIAE) DID NOT REPORT AS EXTENDED SPECTRUM BETA-LACTAMASE (ESBL) POSITIVE. THE USER STATED THEY PERFORMED IMMUNOCHROMATOGRAPHIC STUDY FOR OXA-48, KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC), NEW DELHI METALLO-BETA-LACTAMASE (NDM), VERONA INTEGRON-ENCODED METALLO-BETA-LACTAMASE (VIM), IMIPENEMASE (IMP) AND KIRBY BAUER TESTING. THE RESULTS WERE POSITIVE FOR CARBAPENEMASE AND ESBL NEGATIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076460 PANEL PHOENIX NMIC/ID-485 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 1051750 00382904495268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown