BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC-107

    MDR report key: 20135873 · Received September 4, 2024

    Report

    Report Number
    1119779-2024-00658
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904484171
    PMA / PMN Number
    SEE H.11
    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

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. 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. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-107, A PATIENT ISOLATE HAD A HIGH MIC FOR THE DRUG VANCOMYCIN. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC VANCOMYCIN (VA) WHEN USING PHOENIX PANEL PMIC-107 (CATALOG NUMBER 448417) BATCH NUMBER 3353083. THE CUSTOMER DID NOT PROVIDE ISOLATES, PANEL RETURNS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED A PHOTO FOR THE INVESTIGATION. THE PHOTO SHOWS THE SEQUENCE NUMBERS AND DATES USED FOR THE PHOENIX PANELS. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES STAPHYLOCOCCUS AUREUS A43300, STAPHYLOCOCCUS AUREUS 4757, STAPHYLOCOCCUS AUREUS A29213 AND STAPHYLOCOCCUS AUREUS A25923 THEN PLACED IN A PHOENIX M50 FOR VA MIC RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE STAPHYLOCOCCUS AUREUS A43300 THEN PLACED IN A PHOENIX M50 FOR VA MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED MIC FOR VA WITH S. AUREUS. THIS COMPLAINT IS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-107 TWO (2) PATIENT ISOLATES HAVE A HIGH MIC FOR THE DRUG VANCOMYCIN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-107, A PATIENT ISOLATE HAD A HIGH MIC FOR THE DRUG VANCOMYCIN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-107 TWO (2) PATIENT ISOLATES HAVE A HIGH MIC FOR THE DRUG VANCOMYCIN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080030 BD PHOENIX¿ PMIC-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 3353083 30382904484171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown