BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 14735230 · Received June 17, 2022

    Report

    Report Number
    1119779-2022-00901
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    April 26, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BD PHOENIX NMIC-306 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K181665, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K032567, K060257, K023634, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932. 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 NOT CONFIRMED. THIS COMPLAINT IS FOR FALSE RESISTANCE OF ERTAPENEM (ETP) WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH NUMBERS 2033038, 2033009, 2040905, 2067289, AND 2046656. TO INVESTIGATE, A TOTAL OF SIX RETENTION PANELS FROM EACH COMPLAINT BATCH WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI (A25922) AND IN HOUSE ISOLATES OF KLEBSIELLA PNEUMONIAE (11061), THREE PANELS WERE TESTED PER ISOLATE ON PHOENIX INSTRUMENT AND EVALUATED FOR ERTAPENEM (ETP) MIC RESULTS. BATCH 2040905 RETENTIONS WERE NOT AVAILABLE AT THE TIME OF INVESTIGATION. DURING INVESTIGATION, ALL PANELS TESTED WITH BOTH ISOLATES YIELDED SATISFACTORY RESULTS FOR ERTAPENEM (ETP) AT AN MIC OF =0.25 WITH THE EXPECTED RESULT AS =0.5. THIS COMPLAINT IS NOT CONFIRMED FOR FALSE RESISTANCE. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS FOR THE COMPLAINT BATCHES EXCEPT COMPLAINT BATCH 2040905 DID HAVE ON ADDITIONAL COMPLAINT. 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. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 2.0-2.14, INDICATES THE POTENTIAL RISK OF A FALSE RESISTANT RESULT AS AN S3. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    REPORT 6 OF 17. IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX PANEL NMIC-306, FALSE RESISTANT RESULTS WERE OBTAINED. CONFIRMATORY E-TESTING WAS PERFORMED AND THE RESULTS WERE SUSCEPTIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING HIGH MIC VALUE FOR ERTAPENAM WITH THEIR NMIC 306 PANELS CUSTOMER IS REPORTING THEY ARE SEEING AN ISSUE WITH THEIR NMIC PANELS CALLING ERTAPENAM RESISTANT 1-2. WHEN THEY SET UP AN E-TEST THE ISOLATE IS SUSCEPTIBLE. THIS POSES AN ISSUE WITH INFECTION CONTROL AS THESE ARE REPORTED AS CRO. THEY ARE CURRENTLY SUPPRESSING ERTAPENEM RESULTS UNTIL A E TEST CONFIRMATION IS RUN AND WANT TO KNOW IF ANY OTHER LABS HAVE HAD THIS ISSUE.

    Description of Event or Problem · 0

    REPORT 6 OF 17 IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX PANEL NMIC-306, FALSE RESISTANT RESULTS WERE OBTAINED. CONFIRMATORY E-TESTING WAS PERFORMED AND THE RESULTS WERE SUSCEPTIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING HIGH MIC VALUE FOR ERTAPENAM WITH THEIR NMIC 306 PANELS CUSTOMER IS REPORTING THEY ARE SEEING AN ISSUE WITH THEIR NMIC PANELS CALLING ERTAPENAM RESISTANT 1-2. WHEN THEY SET UP AN E-TEST THE ISOLATE IS SUSCEPTIBLE. THIS POSES AN ISSUE WITH INFECTION CONTROL AS THESE ARE REPORTED AS CRO. THEY ARE CURRENTLY SUPPRESSING ERTAPENEM RESULTS UNTIL A E TEST CONFIRMATION IS RUN AND WANT TO KNOW IF ANY OTHER LABS HAVE HAD THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194002 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 2033009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown