BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 20896208 · Received December 10, 2024

    Report

    Report Number
    1119779-2024-00974
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 14, 2024
    Report Date
    May 16, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492923
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR INCORRECT AMBLER CPO CLASSIFICATION FOR PROTEUS MIRABILIS WHEN USING PHOENIX PANEL (B)(6) (CATALOG NUMBER 449292) BATCH NUMBER 4233340. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, PHOENIX GENERATED LAB REPORTS OR ISOLATES BUT PROVIDED A PHOTO OF MIC RESULTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED WITH IN HOUSE ISOLATE P. MIRABILIS (B)(6) FOR CPO RESULTS. ALL PANELS RETURNED NEGATIVE CPO CLASS B RESULTS. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. BDXPERT SYSTEM UPDATES WERE IMPLEMENTED IN PHOENIX UPDATE DISK (PUD) V7.51. RULE 1826 WAS UPDATED TO ADDRESS THE POTENTIAL FOR FIRING WHEN THE ISOLATE IS CPO NEGATIVE. IT IS RECOMMENDED TO UPDATE TO THE LATEST PUD AND REFER TO THE PUD RELEASE NOTES FOR ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. 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, AND K123266. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ (B)(6) A PATIENT ISOLATE (PROTEUS MIRABILIS) GAVE A CLASS B CPO ALERTHIGH MICS) AND AN INVALID RESULT. THE USER WAS REQUIRED TO USE A BACKUP PLATFORM FOR VALID RESULTS. THIS PLATFORM GAVE CARBAPENEMS SUSCEPTIBLE WHICH WAS NOT EXPECTED FROM A CPO ORGANISM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE (PROTEUS MIRABILIS) GAVE A CLASS B CPO ALERTHIGH MICS) AND AN INVALID RESULT. THE USER WAS REQUIRED TO USE A BACKUP PLATFORM FOR VALID RESULTS. THIS PLATFORM GAVE CARBAPENEMS SUSCEPTIBLE WHICH WAS NOT EXPECTED FROM A CPO ORGANISM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534310 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4233340 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown