BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 22895343 · Received August 26, 2025

    Report

    Report Number
    1119779-2025-04393
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    March 7, 2023
    Report Date
    July 1, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER ADDR 1: (B)(6). INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF E. COLI AS CITROBACTER KOSERI OR ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 2319818.THE CUSTOMER PROVIDED PHOENIX GENERATED LAB REPORTS, ISOLATES AND PANEL RETURNS FOR THE INVESTIGATION. TO INVESTIGATE, THE CUSTOMER RETURNED PANELS FROM COMPLAINT BATCH 2319818 WERE TESTED USING CUSTOMER RETURNED E. COLI ISOLATES (00428-1, 00428-2 AND 00491) ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. DURING THE INVESTIGATION, ALL PANELS IDENTIFIED AS E. COLI. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH, NOT RELATED TO THIS DEFECT. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT ACROSS THIS PANEL SKU (#449289). THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PANEL PHOENIX NMIC/ID-307, A PATIENT SAMPLE WAS INCORRECTLY IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723557 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 2319818 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown