BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 20623153 · Received November 6, 2024

    Report

    Report Number
    1119779-2024-00815
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 25, 2024
    Report Date
    March 28, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHEN USING BD PHOENIX¿ NMIC-(B)(6), ERRONEOUS PATIENT RESULTS WERE ATTAINED FOR CEFUROXIME (HIGH MIC RESULTS). THERE WAS NO CONFIRMATORY TESTING INFORMATION PROVIDED, THIS REPORT WAS MADE ON THE COMPARISON OF RESULTS BETWEEN CEFUROXIME AND CEFAZOLIN. THERE WAS NO REPORT OF PATIENT IMPACT. D4. MEDICAL DEVICE LOT#: 4233342 D4. MEDICAL DEVICE EXPIRATION DATE: 14-AUG-2025 D4. UNIQUE IDENTIFIER (UDI) #(B)(4). H.4. DEVICE MANUFACTURE DATE: 20-AUG-2024 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC CEFUROXIME (CXM) AND CEFAZOLIN (CZ) WHEN USING PHOENIX PANEL NMIC-306(CATALOG NUMBER 449292) BATCH NUMBERS 4233342 AND 4248245. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES AND BINARY FILES FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE TWO COMPLAINT BATCHES WERE INOCULATED WITH CUSTOMER RETURNED AND IN HOUSE ISOLATES ESCHERICHIA COLI WD-1 THROUGH WD-7, CITROBACTER KOSERI WD-8, ESCHERICHIA COLI ENF (B)(6), CITROBACTER KOSERI ENF (B)(6)AND CITROBACTER KOSERI FR-6 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR CXM AND CZ MIC RESULTS. NEXT, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED AND IN HOUSE ISOLATES ESCHERICHIA COLI WD-1 THROUGH WD-7, CITROBACTER KOSERI WD-8, ESCHERICHIA COLI ENF11071, CITROBACTER KOSERI ENF (B)(6) AND CITROBACTER KOSERI FR-6 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR CXM AND CZ MIC RESULTS. FOR FURTHER INVESTIGATION, DISC DIFFUSION TESTING WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATES ESCHERICHIA COLI WD-1 THROUGH WD-7 AND CITROBACTER KOSERI WD-8. DISC DIFFUSION RESULTS SHOW MIC VALUES TO BE THE SAME RESULTS AS INTERNAL TESTING OF PHOENIX PANELS OR WITHIN ONE DILUTION OF THE EXPECTED RESULT. BD DOES NOT CONFIRM ON AN INTERMEDIATE (I) RESULT AS IT IS ONE DILUTION OFF FROM SENSITIVE (S) OR RESISTANT (R). PER CLSI M23(DEVELOPMENT OF IN VITRO SUSCEPTIBILITY TEST METHODS, BREAKPOINTS, AND QUALITY CONTROL PARAMETERS), THE DECISION TO REPORT INTERMEDIATE RESULTS IS BEST MADE BY EACH LABORATORY BASED ON INSTITUTION-SPECIFIC GUIDELINES. 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 TWO BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. G.5. MATERIAL 449292 - THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE IMPLICATED 510K ARE AS FOLLOWS: 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. 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 THAT WHEN USING BD PHOENIX¿ NMIC-306, ERRONEOUS PATIENT RESULTS WERE ATTAINED FOR CEFUROXIME (HIGH MIC RESULTS). THERE WAS NO CONFIRMATORY TESTING INFORMATION PROVIDED, THIS REPORT WAS MADE ON THE COMPARISON OF RESULTS BETWEEN CEFUROXIME AND CEFAZOLIN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING BD PHOENIX¿ NMIC-306, ERRONEOUS PATIENT RESULTS WERE ATTAINED FOR CEFUROXIME (HIGH MIC RESULTS). THERE WAS NO SPECIFIC LOT NUMBER PROVIDED. THERE WAS NO CONFIRMATORY TESTING INFORMATION PROVIDED, THIS REPORT WAS MADE ON THE COMPARISON OF RESULTS BETWEEN CEFUROXIME AND CEFAZOLIN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428425 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4233342 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown