BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 23235187 · Received October 7, 2025

    Report

    Report Number
    1119779-2025-05046
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 10, 2025
    Report Date
    March 4, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR CLINDAMYCIN (CC) WHEN USING PANEL PHOENIX PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER 5099093. THE CUSTOMER RETURNED BINARY FILES 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 HIGH MIC RESULTS FOR PANEL SKU 449036. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE STAPHYLOCOCCUS AUREUS POS 6532 TO OBSERVE FOR CC MIC RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE STAPHYLOCOCCUS AUREUS POS 6532 TO OBSERVE FOR CC MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SATISFACTORY SUSCEPTIBLE CC SIR AND MIC RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED TO NOT BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. 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 HIGH MIC (FALSE RESISTANCE) FOR THE DRUG CLINDAMYCIN. THE USER NOTED ERRONEOUS RESULTS WERE REPORTED TO THE PROVIDER AND A CORRECTIVE REPORT WAS SENT AFTER THE MANUAL D TEST WAS PERFORMED. THE CUSTOMER ALSO NOTED THAT NO INFORMATION ON IF THERE WAS PATIENT TREATMENT CHANGE AS A RESULT. REPORT 1 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE HAD HIGH MIC (FALSE RESISTANCE) FOR THE DRUG CLINDAMYCIN. THE USER NOTED ERRONEOUS RESULTS WERE REPORTED TO THE PROVIDER AND A CORRECTIVE REPORT WAS SENT AFTER THE MANUAL D TEST WAS PERFORMED. THE CUSTOMER ALSO NOTED THAT NO INFORMATION ON IF THERE WAS PATIENT TREATMENT CHANGE AS A RESULT. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869235 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5099093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown