BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 20786104 · Received November 26, 2024

    Report

    Report Number
    1119779-2024-00929
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 8, 2024
    Report Date
    January 15, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486069
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. 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, 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 OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS EPIDERMIDIS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) 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¿ PMIC/ID-106 A PATIENT RESULT, S. AUREUS, WAS MISIDENTIFIED AS 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 A PATIENT RESULT, S. AUREUS, WAS MISIDENTIFIED AS S. EPIDERMIDIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367544 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382904486069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown