BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 20071735 · Received August 26, 2024

    Report

    Report Number
    1119779-2024-00637
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 5, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486069
    PMA / PMN Number
    SEE H.11
    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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF S. AUREUS AND S. EPIDERMIDIS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 4065777. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, BINARY FILES, ISOLATES OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING IN HOUSE S. AUREUS (POS 11873) AND S. EPIDERMIDIS (POS 6537) ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, RETENTION PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE ALSO TESTED USING IN HOUSE S. AUREUS (POS 11873) AND S. EPIDERMIDIS (POS 6537) ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED IDENTIFIED THE ISOLATES CORRECTLY, THEREFORE 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. PMA / 510(K)#: K020322, K021954, K022172, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050555, K051689, K053241, K060214, K060217, K060218, K060218, K060493, K082538, K082852, K082913, 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 WHILE USING THE BD PHOENIX¿ PMIC/ID-106 AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE MISIDENTIFIED AS EITHER S. AUREUS OR S EPIDERMIDIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-106 AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE MISIDENTIFIED AS EITHER S. AUREUS OR S EPIDERMIDIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219727 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4065777 30382904486069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown