BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ SMIC-101

    MDR report key: 22636456 · Received July 28, 2025

    Report

    Report Number
    1119779-2025-02033
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 28, 2025
    Report Date
    September 4, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904488032
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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)#: K032675, K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, AND K062206. 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 11-JUL-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR INCORRECT BREAKPOINTS WHEN USING PHOENIX PANEL SMIC-101 (CATALOG NUMBER 448803) BATCH NUMBER 5070677. THE CUSTOMER PROVIDED PANEL RETURNS, BINARY FILES, ISOLATE RETURNS AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW VARIED MICS FOR CLINDAMYCIN (CC) AND ERYTHROMYCIN (E) WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE STREPTOCOCCUS AGALACTIAE 4101 TO OBSERVE FOR CC AND E MIC RESULTS. ALSO, RETENTION PANELS FROM THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE STREPTOCOCCUS AGALACTIAE 4101 TO OBSERVE FOR CC AND E MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SATISFACTORY CC AND E MIC RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. 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. 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 BD PHOENIX¿ SMIC-101 PATIENT ISOLATE RESULTS FOR THE DRUGS ERYTHROMYCIN AND CLINDAMYCIN DO NOT MATCH THE D TEST RESULT NOR REPEAT RESULTS ON THE DEVICE. PATIENT ONE HAD A SENSITIVE CLINDAMYCIN AND A RESISTANT ERYTHROMYCIN RESULT. THE D TEST RESULT SHOWS BOTH CLINDAMYCIN AND ERYTHROMYCIN AS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC-101 A PATIENT ISOLATE RESULTS FOR THE DRUGS ERYTHROMYCIN AND CLINDAMYCIN DO NOT MATCH THE D TEST RESULT NOR REPEAT RESULTS ON THE DEVICE. PATIENT ONE HAD A SENSITIVE CLINDAMYCIN AND A RESISTANT ERYTHROMYCIN RESULT. THE D TEST RESULT SHOWS BOTH CLINDAMYCIN AND ERYTHROMYCIN AS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575682 BD PHOENIX¿ SMIC-101 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5070677 30382904488032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown