BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 20706453 · Received November 18, 2024

    Report

    Report Number
    1119779-2024-00899
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 29, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904486075
    PMA / PMN Number
    K020322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 STAPHYLOCOCCUS EPIDERMIDIS WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER 4128509. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES FOR THE INVESTIGATION. PANEL BATCH 4128509 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A COMPARABLE BATCH WAS USED. TO INVESTIGATE, THREE RETENTION PANELS EACH FROM THE COMPARABLE BATCH AND A CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH NUMBER WERE TESTED USING CUSTOMER RETURNED ISOLATE STAPHYLOCOCCUS AUREUS 24H-300M10028 AND STAPHYLOCOCCUS AUREUS 24H-299M10072 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. PREVIOUS INVESTIGATION OF COMPLAINT BATCH 4128509 SHOWS QC ISOLATES S. AUREUS A29213 AND S. AUREUS A25923 WERE TESTED ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED IDENTIFIED THE ISOLATES AS STAPHYLOCOCCUS AUREUS, 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.

    Additional Manufacturer Narrative · 0

    E.1: INITIAL REPORTER PHONE #: (B)(6). THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G.4. PMA/510(K)#: 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 K13133. A DEVICE EVALUATION IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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, S. AUREUS, WAS MISIDENTIFIED AS S. EPIDERMIDIS. 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, S. AUREUS, WAS MISIDENTIFIED AS S. EPIDERMIDIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089883 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4128509 00382904486075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown