BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 20609031 · Received November 5, 2024

    Report

    Report Number
    1119779-2024-00802
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    September 8, 2024
    Report Date
    February 6, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486076
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS GALLINARUM AS STREPTOCOCCUS AGALACTIAE WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER 4072114. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES, BUT DID PROVIDE BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. REVIEW OF THE LAB REPORTS SHOW PHOENIX IDENTIFICATIONS OF STREPTOCOCCUS AGALACTIAE WHEN USING THE COMPLAINT BATCH. PANEL BATCH 4072114 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A COMPARABLE BATCH WAS USED. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPARABLE BATCH AND A CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH NUMBER WERE TESTED USING IN HOUSE STAPHYLOCOCCUS GALLINARUM ISOLATES ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED IDENTIFIED THE ISOLATES AS STAPHYLOCOCCUS GALLINARUM, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. 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/ID-107 A PATIENT ISOLATE (STAPH GALNARIUM) WAS MISIDENTIFIED AS STREP. GROUP B - STREPTOCOCCUS AGALACTIAE. THE USER NOTED THAT THE ISOLATE WAS CATALASE POSITIVE SIGNIFYING A STAPHYLOCOCCUS SPP. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-107 A PATIENT ISOLATE (STAPH GALNARIUM) WAS MISIDENTIFIED AS STREP. GROUP B - STREPTOCOCCUS AGALACTIAE. THE USER NOTED THAT THE ISOLATE WAS CATALASE POSITIVE SIGNIFYING A STAPHYLOCOCCUS SPP. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120632 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4072114 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown