BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 18436329 · Received January 3, 2024

    Report

    Report Number
    1119779-2023-01473
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    November 25, 2023
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). BD PHOENIX NMIC-306 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. 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, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K163637, K173252, K173523, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K190905. 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 LOW MIC MEROPENEM (MEM) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 3269849. THE CUSTOMER DID NOT PROVIDE ISOLATE RETURNS, PANEL RETURNS BUT PROVIDED BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB RESULTS SHOW LOW MIC MEM RESULTS WITH P. AERUGINOSA WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE P. AERUGINOSA AND PLACED IN A PHOENIX M50 FOR MEM MIC RESULTS. ALSO, THREE CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE P. AERUGINOSA AND PLACED IN A PHOENIX M50 FOR MEM MIC RESULTS. DISC DIFFUSION WAS PERFORMED ON THE TESTED ISOLATES TO VERIFY MEM SUSCEPTIBILITY. RESULTS OF THE INVESTIGATION SHOW THE EXPECTED RESULTS FOR MEM. THIS COMPLAINT IS NOT CONFIRMED. THE BREAKPOINTS PUBLISHED IN CLSI M100, 33RD ED /M45-A3 REMAIN UNCHANGED IN THE BD PHOENIX¿, BD EPICENTER¿, AND BD SYNAPSYS¿ SYSTEMS. THE PUD BREAKPOINTS LISTED IN THIS TABLE ARE NOT ALIGNED WITH THE CURRENT CLSI M100 BREAKPOINTS EITHER DUE TO THESE BREAKPOINTS NOT BEING RECOGNIZED BY THE FDA SUSCEPTIBILITY TESTING INTERPRETIVE CRITERIA (STIC) WEBSITE OR PERFORMANCE WITH THE UPDATED BREAKPOINTS HAS NOT YET BEEN EVALUATED INTERNALLY BY BD FOR THE BD PHOENIX ¿ SYSTEM. AS BD PHOENIX¿ CURRENTLY HAS ONLY ONE CLSI INTERPRETATIONAL RULE SET, THIS BREAKPOINT SET IS INFLUENCED BY THE FDA FOR US CUSTOMERS. SEE ATTACHMENT L: BD PHOENIX¿ PUD CLSI MIC BREAKPOINT LISTING FOR A COMPLETE LIST OF THE CLSI MIC BREAKPOINTS PROVIDED IN PUD V7.31. 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 WHEN USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD A DISCREPANT RESULT FOR THE DRUG MEROPENEM WHEN COMPARED TO THE ETEST STRIP RESULT. THE PANEL RESULT WAS SENSITIVE WHILE THE ETEST WAS INTERMEDIATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD A DISCREPANT RESULT FOR THE DRUG MEROPENEM WHEN COMPARED TO THE ETEST STRIP RESULT. THE PANEL RESULT WAS SENSITIVE WHILE THE ETEST WAS INTERMEDIATE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549549 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3269849 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown