BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 20536788 · Received October 25, 2024

    Report

    Report Number
    1119779-2024-00786
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 29, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486076
    PMA / PMN Number
    SEE H11
    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

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020322, K021954, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, AND K131331. 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 WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER 4072114. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORT SHOWS IDENTIFICATIONS OF STAPHYLOCOCCUS SIMULANS, STAPHYLOCOCCUS INTERMEDIUS, PSEUDOMONAS AERUGINOSA AND KLEBSIELLA OXYTOCA. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING IN HOUSE AND QC ISOLATES S. AUREUS A29213, S. AUREUS A43300, S. AUREUS 4757 AND S. AUREUS 7146 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH QC ISOLATE S. AUREUS A29213 AND PLACED IN A PHOENIX M50 AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THE ISOLATES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-107 A PATIENT'S WOUND ISOLATE (S. AUREUS) WAS MISIDENTIFIED AS S. INTERMEDIUS, THEN WHEN REPEATED IT WAS IDENTIFIED AS S. SIMULANS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-107 A PATIENT'S WOUND ISOLATE (S. AUREUS) WAS MISIDENTIFIED AS S. INTERMEDIUS, THEN WHEN REPEATED IT WAS IDENTIFIED AS S. SIMULANS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812352 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4072114 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown