BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 19404953 · Received May 28, 2024

    Report

    Report Number
    1119779-2024-00424
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    March 29, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10
    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

    G.5: PMA / 510(K)#: K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K181665, K173252, K190905, K163637, K173523, K033458,K123266 H.3. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 17-MAY-2024. INVESTIGATION SUMMARY THIS COMPLAINT IS FOR HIGH MIC FOR CARBAPENEMS WITH ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE AND PROTEUS MIRABILIS WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER (B)(4). THE CUSTOMER DID NOT PROVIDE ISOLATES OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED BINARY FILES AND PANEL RETURNS FOR THE INVESTIGATION. TO INVESTIGATE, TWO CUSTOMER RETURNED PANELS EACH OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES E. COLI ENF 10998, K. PNEUMONIAE ENF 10997 AND P. MIRABILIS ENF 10926 THEN PLACED IN A PHOENIX M50 FOR CARBAPENEM MIC RESULTS. IN ADDITION, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES E. COLI ENF 10998, K. PNEUMONIAE ENF 10997 AND P. MIRABILIS ENF 10926 THEN PLACED IN A PHOENIX M50 FOR CARBAPENEM MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED MIC FOR CARBAPENEMS. THIS COMPLAINT IS NOT CONFIRMED. 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    REPORT 2 OF 17. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX PANEL NMIC-306, THE CUSTOMER RECEIVED A RESISTANT CARBAPENEM RESULT WITH E.COLI. WHEN TESTED MANUALLY WITH KIRBY-BAUER, A SENSITIVE RESULT WAS OBTAINED AND WAS ALSO SENSITIVE UPON REPEAT ON THE PHOENIX INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 17. IT WAS REPORTED THAT WHILE USING THE BD PHOENIX PANEL NMIC-306, THE CUSTOMER RECEIVED A RESISTANT CARBAPENEM RESULT WITH E.COLI. WHEN TESTED MANUALLY WITH KIRBY-BAUER, A SENSITIVE RESULT WAS OBTAINED AND WAS ALSO SENSITIVE UPON REPEAT ON THE PHOENIX INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676832 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 4023035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown