BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 18686457 · Received February 12, 2024

    Report

    Report Number
    1119779-2024-00094
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    November 13, 2023
    Report Date
    June 24, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    30382904480074
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NID (CATALOG NUMBER 448007) BATCH NUMBER 3213037. THE CUSTOMER PROVIDED ISOLATES AND PHOENIX GENERATED LAB REPORTS BUT DID NOT PROVIDE PANELS FOR INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF CITROBACTER FREUNDII, MORGANELLA MORGANII AND ENTEROBACTER CLOACAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS C. FREUNDII L-4, PROTEUS MIRABILIS L-8, P. MIRABILIS L10, P. MIRABILIS L-12, ESCHERICHIA COLI L-1, E. COLI L-5 AND E. COLI L-6. BATCH 3213037 WAS NOT AVAILABLE AT THE TIME OF TESTING AND A COMPARABLE BATCH WAS USED. TO INVESTIGATE, RETENTION SAMPLES FROM THE COMPARABLE BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES C. FREUNDII L-4, P. MIRABILIS L-8, P. MIRABILIS L10, P. MIRABILIS L-12, E. COLI L-1, E. COLI L-5 AND E. COLI L-6. AND PLACED IN A PHOENIX M50 FOR IDENTIFICATION RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES C. FREUNDII L-4, P. MIRABILIS L-8, P. MIRABILIS L10, P. MIRABILIS L-12, E. COLI L-1, E. COLI L-5 AND E. COLI L-6. AND PLACED IN A PHOENIX M50 FOR IDENTIFICATION RESULTS. ALL PANELS INOCULATED WITH CUSTOMER RETURNED ISOLATES L-1, L-12, L-5, L-6 AND L-8 IDENTIFIED THE INOCULATED ISOLATE CORRECTLY. THE PANELS INOCULATED WITH CUSTOMER RETURNED ISOLATES C. FREUNDII L-4 AND P. MIRABILIS L-10 RETURNED MISIDENTIFICATION RESULTS, THIS COMPLAINT IS CONFIRMED. WHILE THERE HAS BEEN AN OBSERVATION OF MISIDENTIFICATIONS BY THE CUSTOMER, BD HAS NOT BEEN ABLE TO REPLICATE THE FAILURE THROUGH INVESTIGATIVE TESTING. AN OVERALL REVIEW OF GRAM-NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. THE TECHNICAL TEAM HAS IDENTIFIED A POTENTIAL ENHANCEMENT THAT WOULD BOLSTER THE INSTRUMENT¿S ABILITY TO INTERPRET THE BEHAVIOR OF E. COLI¿S INTERACTION WITH THE SUBSTRATES ON THE PANEL. BD ANTICIPATES A SOFTWARE RELEASE IN SUMMER 2024 TO ADDRESS THE PERFORMANCE ON E. COLI IDS. BD WILL COMMUNICATE ANY FURTHER UPDATES AS THEY BECOME AVAILABLE. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NO OTHER COMPLAINTS ON THIS BATCH. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Additional Manufacturer Narrative · 0

    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

    REPORT 2 OF 3: IT WAS REPORTED THAT DURING TESTING WITH BD PHOENIX¿ NID, WAS THERE WAS A MISIDENTIFICATION. ACCESSION # (B)(6) IS A MORGANELLA MORGANII CORRECTLY IDENTIFIED DURING INITIAL TESTING, BUT IDENTIFIED AS PROTEUS MIRABILIS DURING REPEAT TESTING WITH SAME PANEL LOT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 3: IT WAS REPORTED THAT DURING TESTING WITH BD PHOENIX¿ NID, WAS THERE WAS A MISIDENTIFICATION. ACCESSION (B)(6) IS A MORGANELLA MORGANII CORRECTLY IDENTIFIED DURING INITIAL TESTING, BUT IDENTIFIED AS PROTEUS MIRABILIS DURING REPEAT TESTING WITH SAME PANEL LOT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465497 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON DICKINSON & CO. (SPARKS) 3213037 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown