BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 22575981 · Received July 23, 2025

    Report

    Report Number
    1119779-2025-01830
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    October 2, 2024
    Report Date
    June 11, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904486075
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G5. ADDITIONAL PMA / 510(K)#: K020322, K021954, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, AND K131331. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR VANCOMYCIN WITH STAPHYLOCOCCUS AUREUS WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT RETURN PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE BATCH NUMBER WAS NOT PROVIDED; THEREFORE, THIS COMPLAINT IS UNCONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. 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. 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 THE BD PHOENIX¿ PMIC/ID-107, THERE WAS A HIGH MIC RESULT FOR A PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036975 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) UNKNOWN 00382904486075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown