BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PID

    MDR report key: 17389736 · Received July 25, 2023

    Report

    Report Number
    1119779-2023-00798
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LQL
    UDI-DI
    30382904480081
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION OF CORYNEBACTERIUM AS ENTEROCOCCUS RAFFINOSUS AND NO-ID RESULTS WHEN USING PHOENIX PANEL PID (448008) BATCH NUMBER 2152720. THE CUSTOMER DID NOT PROVIDE ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR INVESTIGATION. THE LAB REPORTS SHOW AN ORGANISM IDENTIFIED AS E. RAFFINOSUS WHEN USING THE COMPLAINT BATCH. THE COMPLAINT BATCH WAS UNAVAILABLE FOR TESTING DUE TO THE BATCH BEING EXPIRED AT THE TIME OF INVESTIGATION AND BEYOND OUR STABILITY TIMEFRAME. AS A RESULT, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH, RELATED TO MISIDENTIFICATION BUT NOT CONFIRMED. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD PHOENIX¿ PID, A PATIENT SAMPLE WAS INCORRECTLY IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL 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 THAT WHILE USING BD PHOENIX¿ PID, CORYNEBACTERIUM WAS MISIDENTIFIED AS E. RAFFINOSUS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE M50 RETURNED 90% E. RAFFINOSUS INSTEAD OF CORYNEBACTERIUM. THE CUSTOMER REPEATED THE PANEL AND THE PHOENIX RETURNED S. CAPITIS AT 90% INSTEAD OF CORYNEBACTERIUM. THE CUSTOMER DID A THIRD PHOENIX TEST AND THE M50 RETURNED S. CAPITIS AT 90% INSTEAD OF CORYNEBACTERIUM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PID, CORYNEBACTERIUM WAS MISIDENTIFIED AS E. RAFFINOSUS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE M50 RETURNED 90% E. RAFFINOSUS INSTEAD OF CORYNEBACTERIUM. THE CUSTOMER REPEATED THE PANEL AND THE PHOENIX RETURNED S. CAPITIS AT 90% INSTEAD OF CORYNEBACTERIUM. THE CUSTOMER DID A THIRD PHOENIX TEST AND THE M50 RETURNED S. CAPITIS AT 90% INSTEAD OF CORYNEBACTERIUM."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHOENIX¿ PID, A PATIENT SAMPLE WAS INCORRECTLY IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194428 BD PHOENIX¿ PID GRAM POSITIVE IDENTIFICATION PANEL LQL BECTON DICKINSON & CO. (SPARKS) 2152720 30382904480081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown