BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PID

    MDR report key: 20312959 · Received September 26, 2024

    Report

    Report Number
    1119779-2024-00687
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 17, 2024
    Report Date
    November 4, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LQL
    UDI-DI
    30382904480081
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCI WHEN USING PHOENIX PANEL PID (CATALOG NUMBER 448008) BATCH NUMBERS 4072152 AND 4121406. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW AN ISOLATE IDENTIFIED AS STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS EPIDERMIDIS, AND STAPHYLOCOCCUS LUGDENENSIS WHEN USING COMPLAINT BATCHES 4072152 AND 4121406. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCHES WERE TESTED USING IN HOUSE AND QC ISOLATES S. AUREUS A43300 AND S. SAPROPHYTICUS POS 432 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH QC ISOLATES S. AUREUS A29213 AND S. SAPROPHYTICUS POS 432 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATE CORRECTLY, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PID A PATIENT ISOLATE (S. AUREUS) WAS MISIDENTIFIED AS S. EQUORUM. THE USER PERFORMED A LATEX TEST AND OBSERVED THE MACROSCOPE APPEARANCE OF THE BACTERIAL CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 4.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PID A PATIENT ISOLATE (S. AUREUS) WAS MISIDENTIFIED AS S. EQUORUM. THE USER PERFORMED A LATEX TEST AND OBSERVED THE MACROSCOPE APPEARANCE OF THE BACTERIAL CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738596 BD PHOENIX¿ PID GRAM POSITIVE IDENTIFICATION PANEL LQL BECTON DICKINSON & CO. (SPARKS) 4072152 30382904480081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown