BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 22784166 · Received August 12, 2025

    Report

    Report Number
    1119779-2025-03030
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    June 30, 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- 30-JUL-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC LINEZOLID (LZD) AND AMPICILLIN (AM) WHEN USING PHOENIX PANEL PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER 5113759. CUSTOMER RETURNED PANELS, ISOLATES, PHOENIX GENERATED LAB REPORTS AND BINARY FILES WERE AVAILABLE FOR INVESTIGATION. THE CUSTOMER PROVIDED THE FOLLOWING ISOLATES: ENTEROCOCCUS FAECIUM 1 (25V-181CM00048), ENTEROCOCCUS FAECIUM 2 (25C-176MB00179) AND ENTEROCOCCUS FAECIUM 3 (25C-174MB00139.6). TO INVESTIGATE, CUSTOMER RETURNED PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED E. FAECIUM ISOLATES AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD AND AM MIC RESULTS. NEXT, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED E. FAECIUM ISOLATES AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD AND AM MIC RESULTS. LAST, CONTROL PANELS FROM THE SAME MATERIAL BUT A DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED E. FAECIUM ISOLATES AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD AND AM MIC RESULTS. FOR FURTHER INVESTIGATION, DISK DIFFUSION TESTING WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATES. RESULTS OF THE CUSTOMER RETURNED ISOLATES SHOWED SUSCEPTIBLE, INTERMEDIATE AND RESISTANT LZD AND AM MIC RESULTS ACROSS ALL PANELS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATES E. FAECIUM 2 AND E. FAECIUM 3 RETURNED RESISTANT RESULTS FOR AM ON PHOENIX AND DISK DIFFUSION. DISK DIFFUSION RESULTS SHOW THE PHOENIX LZD AND AM MIC VALUES TO BE THE SAME RESULTS (SENSITIVE S OR RESISTANT R) OR WITHIN ONE DILUTION (INTERMEDIATE I) OF THE EXPECTED RESULT LESS THAN OR EQUAL TO 2 (S). AS WE WERE ABLE TO RE-CREATE THE DEFECT REPORTED BY THE CUSTOMER (INTERMEDIATE MIC RESULTS WITH LZD AND E. FAECIUM). THIS COMPLAINT IS CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. 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 LZD AND AM 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 (ENTEROCOCCUS FAECIUM) HAD A HIGH MIC FOR THE DRUGS AMPICILLIN AND LINEZOLID. THE USER NOTED THAT THE FINAL RESULT IS BEING VERIFIED BY A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECIUM) HAD A HIGH MIC FOR THE DRUGS AMPICILLIN AND LINEZOLID. THE USER NOTED THAT THE FINAL RESULT IS BEING VERIFIED BY A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218449 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5113759 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown