BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-485

    MDR report key: 23437795 · Received October 31, 2025

    Report

    Report Number
    1119779-2025-05204
    Event Type
    Malfunction
    Date Received
    October 31, 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION B5. DESCRIBE EVENT OR PROBLEM: 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 1 OF 3.

    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 1 OF 3.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-485, THE USER NOTED THAT AN UNSPECIFIED NUMBER OF PATIENT ISOLATES DID NOT REPORT AS EXTENDED SPECTRUM BETA-LACTAMASE (ESBL) POSITIVE. THE USER STATED WHEN PERFORMING AN IMMUNOCHROMATOGRAPHIC STUDY FOR OXA-48, KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC), NEW DELHI METALLO-BETA-LACTAMASE (NDM), VERONA INTEGRON-ENCODED METALLO-BETA-LACTAMASE (VIM), AND IMIPENEMASE (IMP), RESULTED AS NEGATIVE, AND THE KIRBY BAUER ESBL STUDY RESULTED AS POSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894994 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