BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 20759120 · Received November 22, 2024

    Report

    Report Number
    1119779-2024-00919
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 29, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF KERSTERIA GYIORUM AS ALCALIGENES FAECALIS WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4233325. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF KERSTERIA GYIORUM WHEN USING THE COMPLAINT BATCH. IT IS TO BE NOTED THAT PHOENIX PANEL NMIC/ID-307 DOES NOT HAVE CLAIMS FOR KERSTERIA GYIORUM, THIS COMPLAINT IS NOT CONFIRMED. 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. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE WAS IDENTIFIED AS A. FAECALIS. THE SAME ISOLATE WAS IDENTIFIED AS KERSTERSIA GYIORUM USING MALDI. 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 WAS IDENTIFIED AS A. FAECALIS. THE SAME ISOLATE WAS IDENTIFIED AS KERSTERSIA GYIORUM USING MALDI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798875 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4233325 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown