BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 24052567 · Received January 13, 2026

    Report

    Report Number
    1119779-2026-00005
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 17, 2025
    Report Date
    April 16, 2026
    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
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR LOW MIC RESULTS FOR VANCOMYCIN (VA) WITH ENTEROCOCCUS FAECIUM WHEN USING PANEL PHOENIX PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER 5211429. THE CUSTOMER RETURNED A PHOTO OF RESULTS FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS ANALYZED, AND NO CURRENT TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. HISTORICAL TRENDING WAS REVIEWED AND THERE WERE NO TRENDS FOR LOW MIC RESULTS FOR PANEL SKU 449036. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE ENTEROCOCCUS FAECIUM TO OBSERVE FOR VA MIC RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE ENTEROCOCCUS FAECIUM TO OBSERVE FOR VA MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH RESISTANT VA MIC AND SIR RESULTS FOR THEIR INOCULATED ISOLATES. THEREFORE, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. AS NO COMPLAINT TREND HAS BEEN IDENTIFIED, NO ACTIONS ARE INDICATED AT THIS TIME PER BD PROCEDURES. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECIUM) HAD A LOW MIC (FALSE SUSCEPTIBLE) RESULT FOR THE DRUG VANCOMYCIN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECIUM) HAD A LOW MIC (FALSE SUSCEPTIBLE) RESULT FOR THE DRUG VANCOMYCIN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569363 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5211429 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown