BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 22739517 · Received August 7, 2025

    Report

    Report Number
    1119779-2025-02644
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    June 30, 2025
    Report Date
    October 13, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904490363
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION 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, K023568, K024152, K030091, K030677, K031306, K031679, K032131, K033784, K033889, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K082913, K131331, AND K14046. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THIS COMPLAINT IS FOR HIGH MIC RESULTS WITH VANCOMYCIN (VA) AND DAPTOMYCIN (DAP) WHEN USING PHOENIX PANEL PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER UNKNOWN. CUSTOMER RETURNED PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS WERE NOT AVAILABLE 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 PANEL PHOENIX PMIC-110 THE USER NOTED HIGH MICS FOR THE DRUGS DAPTOMYCIN AND VANCOMYCIN FOR AN UNSPECIFIED NUMBER OF PATIENT ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 THE USER NOTED HIGH MICS FOR THE DRUGS DAPTOMYCIN AND VANCOMYCIN FOR AN UNSPECIFIED NUMBER OF PATIENT ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501643 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown