BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 22576014 · Received July 23, 2025

    Report

    Report Number
    1119779-2025-01837
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    December 6, 2024
    Report Date
    June 11, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR MISIDENTIFICATION OF SERRATIA MARCESCENS AS SERRATIA FONTICOLA AND ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4233325. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND AN ISOLATE FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF SERRATIA FONTICOLA AND ESCHERICHIA COLI WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, EIGHT RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS UPMC-29 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCHES WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS UPMC-29 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. FOUR OF THE EIGHT RETENTION PANELS TESTED RETURNED S. FONTICOLA IDENTIFICATION RESULTS, TWO OF THE CONTROL PANELS TESTED RETURNED E. COLI RESULTS. ALL OTHER PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES AS S. MARCESCENS, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION OF S. MARCESCENS UPMC-29. 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. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE OF SERRATIA MARCESCENS WAS MISIDENTIFIED. THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870997 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4233325 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown