BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 20248303 · Received September 18, 2024

    Report

    Report Number
    1119779-2024-00676
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 25, 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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN LOT NUMBER: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ACINETOBACTER BAUMANNII WHEN USING PHOENIX PANEL NID (CATALOG NUMBER 448007) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT RETURN PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE BATCH NUMBER WAS NOT PROVIDED; THEREFORE, THIS COMPLAINT IS UNCONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NID A PATIENT ISOLATE, ACINETOBACTER BAUMANNII, WAS MISIDENTIFIED AS ESCHERICHIA COLI. THE ISOLATE WAS ALSO IDENTIFIED TO BE A CARBAPENEMASE PRODUCER; THEREFORE, IT WAS SENT TO THE STATE'S LABORATORY WHERE THE RESULT WAS QUESTIONED BECAUSE THE STATE HAD AN IDENTIFICATION OF ACINETOBACTER BAUMANNII. THE USER ALSO CONFIRMED THE ACINETOBACTER BAUMANNII IDENTITY WITH MALDI. THE USER REPEATED THE BD PHOENIX¿ NID TESTING AND GOT THE RESULT ACINETOBACTER BAUMANNII/CALCOACETICUS COMPLEX. THIS RESULTED IN A CORRECTED REPORT FOR THE PATIENT BECAUSE IT HAD INCORRECTLY RESULTED AS A POSSIBLE CARBAPENEMASE PRODUCER, AS WELL AS AN INCORRECT IDENTIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NID A PATIENT ISOLATE, ACINETOBACTER BAUMANNII, WAS MISIDENTIFIED AS ESCHERICHIA COLI. THE ISOLATE WAS ALSO IDENTIFIED TO BE A CARBAPENEMASE PRODUCER; THEREFORE, IT WAS SENT TO THE STATE'S LABORATORY WHERE THE RESULT WAS QUESTIONED BECAUSE THE STATE HAD AN IDENTIFICATION OF ACINETOBACTER BAUMANNII. THE USER ALSO CONFIRMED THE ACINETOBACTER BAUMANNII IDENTITY WITH MALDI. THE USER REPEATED THE BD PHOENIX¿ NID TESTING AND GOT THE RESULT ACINETOBACTER BAUMANNII/CALCOACETICUS COMPLEX. THIS RESULTED IN A CORRECTED REPORT FOR THE PATIENT BECAUSE IT HAD INCORRECTLY RESULTED AS A POSSIBLE CARBAPENEMASE PRODUCER, AS WELL AS AN INCORRECT IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302725 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown