BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ SMIC/ID-101

    MDR report key: 20637504 · Received November 8, 2024

    Report

    Report Number
    1119779-2024-00819
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    September 26, 2024
    Report Date
    February 5, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904488025
    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)#: K032675, K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, AND K062206. 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 WHEN USING PHOENIX PANEL SMIC/ID-101 (CATALOG NUMBER 448802) BATCH NUMBER 4156355. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. REVIEW OF THE LAB REPORTS SHOW PHOENIX IDENTIFICATIONS OF ENTEROCOCCUS WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH AND CONTROL PANELS WERE TESTED USING IN HOUSE STREPTOCOCCUS DYSGALACTIAE AND STREPTOCOCCUS AGALACTIAE ISOLATES ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY WITHIN PASSING PARAMETERS, 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¿ SMIC/ID-101 A PATIENT ISOLATE WAS MISIDENTIFIED. THE USER NOTED THAT THE ISOLATE WAS HAD A LARGE ZONE OF BETA HEMOLYSIS, WAS CAMP TEST NEGATIVE, AND A DISC NEGATIVE. 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¿ SMIC/ID-101 A PATIENT ISOLATE WAS MISIDENTIFIED. THE USER NOTED THAT THE ISOLATE WAS HAD A LARGE ZONE OF BETA HEMOLYSIS, WAS CAMP TEST NEGATIVE, AND A DISC NEGATIVE. THE USER PERFORMED REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951692 BD PHOENIX¿ SMIC/ID-101 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4156355 30382904488025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown