BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 24269369 · Received February 5, 2026

    Report

    Report Number
    1119779-2026-00101
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 11, 2026
    Report Date
    February 23, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS WITH STAPHYLOCOCCUS AUREUS WHEN USING PHOENIX PANEL PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER 5301008. THE CUSTOMER PROVIDED PHOENIX GENERATED LAB REPORTS SHOWING FAILED MIC RESULTS FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. UPON INVESTIGATION FROM AN ONSITE VISIT, IT WAS DISCOVERED THAT THE AP INSTRUMENT WAS CONTAMINATED. IT IS RECOMMENDED TO PERFORM ROUTINE DECONTAMINATION ON THE INSTRUMENTS AND ENVIRONMENT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. 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.

    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 HIGH MIC WERE REPORTED FOR BOTH PATIENT AND QC ISOLATES. THE USER STATED, "PATIENT SPECIMENS WITH STAPH. AUREUS RESULT AS RESISTANT TO VANCOMYCIN (NOT OFTEN), CEPHAZOLIN (NOT OFTEN), CHLORAMPHENICOL (OFTEN), CLINDAMYCIN (OFTEN), AND AMPICILLIN (OFTEN). WHEN THEY REPEAT, THE DRUGS ARE THEN SENSITIVE." THE USER VERIFIED THE FINAL RESULT USING REFERENCE LABORATORY TESTING. IT IS ALSO TO BE NOTED THAT THE UPSTREAM INSTRUMENT WAS FOUND TO BE CONTAMINATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 HIGH MIC WERE REPORTED FOR BOTH PATIENT AND QC ISOLATES. THE USER STATED, "PATIENT SPECIMENS WITH STAPH. AUREUS RESULT AS RESISTANT TO VANCOMYCIN (NOT OFTEN), CEPHAZOLIN (NOT OFTEN), CHLORAMPHENICOL (OFTEN), CLINDAMYCIN (OFTEN), AND AMPICILLIN (OFTEN). WHEN THEY REPEAT, THE DRUGS ARE THEN SENSITIVE." THE USER VERIFIED THE FINAL RESULT USING REFERENCE LABORATORY TESTING. IT IS ALSO TO BE NOTED THAT THE UPSTREAM INSTRUMENT WAS FOUND TO BE CONTAMINATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330332 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5301008 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown