BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 22168184 · Received June 9, 2025

    Report

    Report Number
    1119779-2025-00553
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    January 1, 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: 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, K140468 AND K142170. 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 ON12-DEC-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 NUMBERS 4353555 AND 5042883. CUSTOMER RETURNED PANELS, ISOLATES AND BINARY FILES WERE AVAILABLE FOR INVESTIGATION. THE CUSTOMER PROVIDED THE FOLLOWING ISOLATES: ENTEROCOCCUS FAECIUM (NDX-1, NDX-2, NDX-4, NDX-7 AND NDX-8), ENTEROCOCCUS FAECALIS NDX-6 AND ENTEROCOCCUS CASSELIFLAVUS (NDX-3 AND NDX-5). TO INVESTIGATE, CUSTOMER RETURNED PANELS OF THE TWO COMPLAINT BATCHES WERE INOCULATED WITH CUSTOMER RETURNED E. FAECIUM, E. FAECALIS AND E. CASSELIFLAVUS ISOLATES (NDX 3 THROUGH NDX 8) AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD MIC RESULTS. NEXT, RETENTION PANELS OF THE COMPLAINT BATCHES WERE INOCULATED WITH CUSTOMER RETURNED E. FAECIUM, E. FAECALIS AND E. CASSELIFLAVUS ISOLATES (NDX-1 THROUGH NDX-8) AND PLACED IN A PHOENIX M50 TO EVALUATE FOR LZD MIC RESULTS. LAST, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE ALSO INOCULATED WITH CUSTOMER RETURNED ISOLATES ALONGSIDE IN HOUSE 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 ISOLATES. RESULTS OF THE CUSTOMER RETURNED ISOLATES SHOWED SUSCEPTIBLE AND INTERMEDIATE MIC RESULTS ACROSS BOTH COMPLAINT BATCHES. IN HOUSE ISOLATE E. FAECIUM POS 2277 RETURNED SUSCEPTIBLE MIC RESULTS. DISK DIFFUSION RESULTS SHOW THE PHOENIX MIC VALUES TO BE THE SAME RESULTS (SENSITIVE S) 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, E. FAECALIS AND E. CASSELIFLAVUS). THIS COMPLAINT IS CONFIRMED. BD R&D PERFORMED A BIOCHEMICAL ANALYSIS OF THE CUSTOMER PROVIDED BINARY FILE. THERE WERE NO RESULTS IN THE CHEMICAL REACTIONS THAT STOOD OUT TO BE A DEFINITIVE CAUSE OF THE FALSE RESISTANCE AND NO SIGNS OF CONTAMINATION OBSERVED IN THE WELLS. 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 (ENTEROCOCCUS FAECIUM) HAD INTERMEDIATE OR RESISTANT (HIGH) MICS FOR THE DRUG LINEZOLID. THE USER NOTED THAT THE RESULTS FROM A REFERENCE LABORATORY WERE SUSCEPTIBLE. 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 INTERMEDIATE OR RESISTANT (HIGH) MICS FOR THE DRUG LINEZOLID. THE USER NOTED THAT THE RESULTS FROM A REFERENCE LABORATORY WERE SUSCEPTIBLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332746 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4353555 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown