BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 22833305 · Received August 18, 2025

    Report

    Report Number
    1119779-2025-03518
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    December 10, 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D1. DEVICE MEDICAL BRAND NAME: BD PHOENIX¿ NMIC306. D4. MEDICAL DEVICE LOT #: 5063732. D4. MEDICAL DEVICE EXPIRATION DATE: 01-MAR-2026. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D10. DEVICE AVAILABLE FOR EVAL- YES. D10. RETURNED TO MANUFACTURER ON 12-AUG-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. H4. DEVICE MANUFACTURE DATE: 03-APR-2025. THIS COMPLAINT IS FOR FALSE POSITIVE CPO WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5063732. CUSTOMER RETURNED ISOLATES, BINARY FILES AND PANELS WERE PROVIDED FOR THE INVESTIGATION. TO INVESTIGATE, CUSTOMER RETURNED PANELS AND RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE PROTEUS VULGARIS 2537999.2 AND QC ISOLATE ESCHERICHIA COLI A25922 AND PLACED IN A PHOENIX M50 MACHINE AND EVALUATED FOR CPO FLAGS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT A DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE PROTEUS VULGARIS 2537999.2 AND PLACED IN A PHOENIX M50 MACHINE AND EVALUATED FOR CPO FLAGS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATE P. VULGARIS 2537999.2 RETURNED CPO POSITIVE FLAGS, THE PANELS TESTED WITH QC ISOLATE E. COLI A25922 RETURNED THE EXPECTED CPO NEGATIVE FLAGS. AN MCIM TEST FOR CARBAPENEMASE PRODUCTION WAS PERFORMED ON CUSTOMER RETURNED ISOLATE. THE RESULTS OF THE MCIM TEST SHOWS THAT THE ISOLATE IS CARBAPENEMASE NEGATIVE. THIS COMPLAINT IS CONFIRMED FOR FALSE POSITIVE CPO RESULTS. PHOENIX CPO DETECT TEST UTILIZES A WORKFLOW OF OBSERVING RESISTANCE AND INHIBITION OF CARBAPENEMS AND CARBAPENEMS IN COMBINATION WITH CLASS SPECIFIC INHIBITORS TO PRODUCE A RESULT FOR THE CPO DETECT TEST. THIS TEST IS INDEPENDENT FROM THE CARBAPENEMS ON THE PHOENIX PANELS USED TO DETERMINE MIC. DUE TO THE BROAD RANGE OF DIFFERENT TYPES OF CARBAPENEM RESISTANCE MECHANISMS, THE CPO DETECT TEST CAN HAVE A LOW SPECIFICITY, ESPECIALLY IF USED IN AN INSTITUTION WITH A LOW PREVALENCE OF CARBAPENEMASE-PRODUCING ORGANISMS. CARBAPENEMASE-PRODUCING ORGANISMS WITH SUSCEPTIBLE CARBAPENEM SIR RESULTS HAVE BEEN DESCRIBED, AND CUSTOMERS SHOULD BE REMINDED THAT THIS TEST SHOULD BE USED IN CONJUNCTION WITH MIC TO EVALUATE ROUTINE CLINICAL ISOLATES. 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. 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

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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, 031530, K031699, K031912, K032299, K032567, K032655, K032675, K033362, K033458, K033558, K033560, K041384, K042932, K052269, K060214, 060217, K060257, K060444, K060447, K061327, K061355, K061867, K062207, K062944, K063301, AND K06348. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE (PROTEUS VULGARIS) WAS IDENTIFIED AS A CARBAPENEMASE-PRODUCING ORGANISMS (CPO) WHILE THE CARBAPENEMS WERE ALL SUSCEPTIBLE. THE USER NOTED THAT ALL RESULTS WERE VERIFIED BY AN ALTERNATIVE METHOD. 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 VULGARIS) WAS IDENTIFIED AS A CARBAPENEMASE-PRODUCING ORGANISMS (CPO) WHILE THE CARBAPENEMS WERE ALL SUSCEPTIBLE. THE USER NOTED THAT ALL RESULTS WERE VERIFIED BY AN ALTERNATIVE METHOD. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238958 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5063732 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown