BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18386221 · Received December 22, 2023

    Report

    Report Number
    1119779-2023-01427
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    December 1, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H.10
    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

    BD PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. PMA / 510(K)#: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320. 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

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS CITROBACTER BRAKII WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3241425. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW A PATIENT ISOLATE IDENTIFIED AS E. COLI AND C. BRAKII ON THE COMPLAINT BATCH. TO INVESTIGATE, TWO RETENTION PANELS FROM COMPLAINT BATCH 3241425 WERE TESTED USING IN HOUSE ISOLATE E. COLI ENF 9924 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE E. COLI ENF 9924 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE FOUR PANELS TESTED IDENTIFIED THE ISOLATE AS E. COLI, 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. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED FOR THIS ISSUE. THE TECHNICAL TEAM HAS IDENTIFIED A POTENTIAL ENHANCEMENT THAT WOULD BOLSTER THE INSTRUMENT¿S ABILITY TO INTERPRET THE BEHAVIOR OF E. COLI¿S INTERACTION WITH THE SUBSTRATES ON THE PANEL. BD ANTICIPATES A SOFTWARE RELEASE IN SUMMER 2024 TO ADDRESS THE PERFORMANCE ON E. COLI IDS. BD WILL COMMUNICATE ANY FURTHER UPDATES AS THEY BECOME AVAILABLE. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. 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 ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE PANEL PHOENIX NMIC/ID-307, A PATIENT SAMPLE OF E. COLI WAS MISIDENTIFIED AS CITROBACTER BRAAKII. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE PANEL PHOENIX NMIC/ID-307, A PATIENT SAMPLE OF E. COLI WAS MISIDENTIFIED AS CITROBACTER BRAAKII. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296936 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3241425 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female