BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ SMIC/ID-101

    MDR report key: 20918966 · Received December 12, 2024

    Report

    Report Number
    1119779-2024-00978
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 20, 2024
    Report Date
    March 4, 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
    IL, 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 OF STAPHYLOCOCCUS AUREUS WHEN USING PHOENIX PANEL SMIC/ID-101 (CATALOG NUMBER 448802) BATCH NUMBER 4044939. THE CUSTOMER RETURNED PANELS, AN ISOLATE AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW S. AUREUS A25923 IDENTIFIED AS STREPTOCOCCUS AGALACTIAE. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS S. AUREUS. TO INVESTIGATE, THREE RETENTION PANELS OF THE COMPLAINT BATCH AND ONE CONTROL PANEL WERE TESTED USING CUSTOMER RETURNED ISOLATE S. AUREUS ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED DID NOT IDENTIFY THEIR INOCULATED ISOLATE. THIS COMPLAINT IS NOT CONFIRMED. A STREPTOCOCCUS ISOLATE IS RECOMMENDED FOR A STREP PANEL. 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS - MRSA) WAS MISIDENTIFIED AS GROUP B STREP. REPEAT TESTING WAS PERFORMED CAUSING THE ISOLATE TO BE MISIDENTIFIED TWICE. THE USER NOTED THAT THE ISOLATE DID NOT APPEAR TO BE A STREP THEREFORE, THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY GIVING THE CONFIRMED RESULT OF MRSA. 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 (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS - MRSA) WAS MISIDENTIFIED AS GROUP B STREP. REPEAT TESTING WAS PERFORMED CAUSING THE ISOLATE TO BE MISIDENTIFIED TWICE. THE USER NOTED THAT THE ISOLATE DID NOT APPEAR TO BE A STREP THEREFORE, THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY GIVING THE CONFIRMED RESULT OF MRSA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414235 BD PHOENIX¿ SMIC/ID-101 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4044939 30382904488025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown