BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 18351204 · Received December 18, 2023

    Report

    Report Number
    1119779-2023-01375
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    November 23, 2023
    Report Date
    May 9, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904486075
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS CORYNEBACTERIUM WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER 3150503. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES FOR THE INVESTIGATION. THE CUSTOMER RETURNED ISOLATES WERE GRAM NEGATIVE ISOLATES AND NOT USED IN COMPLAINT TESTING. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING QC ISOLATE S. AUREUS A29213 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALSO, THREE CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH QC ISOLATES S. AUREUS A25923 AND S. AUREUS A29213 TO OBSERVE FOR MISIDENTIFICATION. THE NINE PANELS TESTED IDENTIFIED THE ISOLATE AS S. AUREUS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Additional Manufacturer Narrative · 0

    THE BD PHOENIX BD PHOENIX¿ PMIC/ID-107 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K021954, K023273, K023301, K024152, K030677, K031306, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K131331. 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 THAT DURING USE WITH THE BD PHOENIX¿ PMIC/ID-107, STAPH AUREUS WAS MISIDENTIFIED AS CORONYBACTERIUM JEIKEIUM. THE PATIENT'S MEDICATION WAS CHANGED DUE TO THE FALSE RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ PMIC/ID-107, STAPH AUREUS WAS MISIDENTIFIED AS CORONYBACTERIUM JEIKEIUM. THE PATIENT'S MEDICATION WAS CHANGED DUE TO THE FALSE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78135 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3150503 00382904486075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other