BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 23414692 · Received October 29, 2025

    Report

    Report Number
    1119779-2025-05198
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 9, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE NEGATIVE CPO OF ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 5196514. THE CUSTOMER PROVIDED BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW RESISTANCE TO ERTAPENEM BUT SUSCEPTIBILITY TO MEROPENEM WHEN USING THE COMPLAINT BATCH. 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. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE E. COLI 18187 ON A PHOENIX M50 MACHINE AND EVALUATED FOR CPO RESULTS. ALL PANELS TESTED RETURNED SATISFACTORY CARBAPENEM MIC AND CPO POSITIVE RESULTS. R&D REVIEWED THE CUSTOMER'S BINARY FILES, TO RECAP: -- CUSTOMER¿S PHOENIX DID NOT REPORT AN E. COLI AS CPO+, WHILE A MANUAL NG BIOTECH TEST DETECTED AN OXA-48-LIKE CARBAPENEMASE. -- CUSTOMER¿S LAB REPORT INDICATES RESISTANCE TO ERTAPENEM (MIC >1), BUT SUSCEPTIBILITY TO MEROPENEM (MIC <= 0.5). R&D ANALYZED THE ERTAPENEM, MEROPENEM AND CPO DETECT WELLS, NO UNUSUAL ACTIVITY WAS OBSERVED THAT WOULD SUGGEST CONTAMINATION OR OTHER GROWTH ISSUES. PHOENIX CPO DETECT TEST UTILIZES A WORKFLOW OF OBSERVING RESISTANCE AND INHIBITION OF 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. BASED ON THE INVESTIGATION, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. 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)#: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, 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¿ NMIC/ID-307 A PATIENT ISOLATE (ESCHERICHIA COLI) RESULTED AS CARBAPENEMASE-PRODUCING ORGANISMS (CPO) NEGATIVE WHILE CONFIRMATORY TESTING, USING NG-TEST® CARBA-5, WAS POSITIVE AND EXPRESSING THE OXA-48 GENE. THE USER ALSO NOTED FALSE NEGATIVE CPO RESULTS WHEN PERFORMING COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEYS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (ESCHERICHIA COLI) RESULTED AS CARBAPENEMASE-PRODUCING ORGANISMS (CPO) NEGATIVE WHILE CONFIRMATORY TESTING, USING NG-TEST® CARBA-5, WAS POSITIVE AND EXPRESSING THE OXA-48 GENE. THE USER ALSO NOTED FALSE NEGATIVE CPO RESULTS WHEN PERFORMING COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEYS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686545 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5196514 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown