BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 23073642 · Received September 17, 2025

    Report

    Report Number
    1119779-2025-04983
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    December 15, 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
    ME, 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, 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION D10. DEVICE AVAILABLE FOR EVAL- YES. D10. RETURNED TO MANUFACTURER ON 24-SEP-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC LINEZOLID (LZD) WHEN USING PHOENIX PANEL PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER 5148706. CUSTOMER RETURNED PANELS AND ISOLATE WERE PROVIDED FOR THE INVESTIGATION. THE CUSTOMER PROVIDED THE FOLLOWING ISOLATES: ENTEROCOCCUS FAECIUM (NDX-10). TO INVESTIGATE, CUSTOMER RETURNED PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED AND IN HOUSE ISOLATES E. FAECIUM NDX-10 AND E. FAECIUM POS 2277 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD MIC RESULTS. NEXT, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE ALSO INOCULATED WITH CUSTOMER RETURNED AND IN HOUSE ISOLATES E. FAECIUM NDX-10 AND E. FAECIUM POS 2277 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD RESULTS. FOR FURTHER INVESTIGATION, DISK DIFFUSION TESTING WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATE. RESULTS OF THE CUSTOMER RETURNED ISOLATE SHOWED INTERMEDIATE MIC RESULTS ACROSS ALL PANELS INOCULATED. IN HOUSE ISOLATE E. FAECIUM POS 2277 RETURNED SUSCEPTIBLE MIC RESULTS. DISK DIFFUSION RESULTS RETURNED RESISTANT MIC RESULTS FOR CUSTOMER RETURNED ISOLATE E. FAECIUM NDX-10. NOTE: BD DOES NOT CONFIRM ON AN INTERMEDIATE (I) VERSUS RESISTANT (R) RESULT, AS IT IS ONE BREAKPOINT APART AND WITHIN THE MARGIN OF ERROR. THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD REVIEW FOR THE COMPLAINT BATCHES WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OR INSPECTION. FORMULATION, FILLING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS ARE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. FOR FURTHER REVIEW, COMPLAINTS DUE TO HIGH MIC LINEZOLID (LZD) ACROSS THIS MATERIAL (#449036) WERE REVIEWED AND THERE ARE NO TRENDS ASSOCIATED WITH THIS DEFECT. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. 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 A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG LINEZOLID WHILE THE E -TEST AND REFERENCE LABORATORY RESULT IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG LINEZOLID WHILE THE E -TEST AND REFERENCE LABORATORY RESULT IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706204 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5148706 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown