BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 24043548 · Received January 12, 2026

    Report

    Report Number
    1119779-2025-05557
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 2, 2026
    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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STREPTOCOCCUS GROUP B WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER 5266575. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS AND AN ISOLATE FOR THE INVESTIGATION. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED AND LABELED AS S. AUREUS WITH A BRUKER MALDI BIOTYPER. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE AND CUSTOMER RETURNED ISOLATES S. AUREUS 3605 AND S. AUREUS A29213 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS INOCULATED WITH IN HOUSE ISOLATE S. AUREUS A29213 TESTED IDENTIFIED THEIR INOCULATED ISOLATE CORRECTLY. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATE S. AUREUS 3605 IDENTIFIED THE ISOLATE AS S. AUREUS AND STREPTOCOCCUS AGALACTIAE (STREPTOCOCCUS GROUP B), THEREFORE THIS COMPLAINT IS 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.

    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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-107 A PATIENT ISOLATE (STAPHYLOCOCCUS AUREUS) WAS MISIDENTIFIED AS GROUP B STREP (GBS) OR STREPTOCOCCUS AGALACTIAE. THE USER VERIFIED THE FINAL RESULT USING CATALASE AND COAGULASE. THE USER ALSO NOTED PERFORMING REPEAT TESTING AND THAT THE ISOLATE WAS COAGULASE POSITIVE AND BETA HEMOLYTIC. 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 (STAPHYLOCOCCUS AUREUS) WAS MISIDENTIFIED AS GROUP B STREP (GBS) OR STREPTOCOCCUS AGALACTIAE. THE USER VERIFIED THE FINAL RESULT USING CATALASE AND COAGULASE. THE USER ALSO NOTED PERFORMING REPEAT TESTING AND THAT THE ISOLATE WAS COAGULASE POSITIVE AND BETA HEMOLYTIC. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295066 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5266575 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown