BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ SMIC/ID-101

    MDR report key: 24394229 · Received February 19, 2026

    Report

    Report Number
    1119779-2026-00231
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    December 21, 2025
    Report Date
    April 14, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904488025
    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 INCORRECT BREAKPOINTS WITH TRIMETHOPRIM-SULFAMETHOXAZOLE (SXT) WITH STREPTOCOCCUS PNEUMONIAE WHEN USING PHOENIX PANEL SMIC/ID-101 (CATALOG NUMBER 448802) BATCH NUMBER 5014275. CUSTOMER RETURNED PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS WERE NOT AVAILABLE 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. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS WERE INOCULATED WITH IN HOUSE ISOLATES S. PNEUMONIAE A49619 AND S. PNEUMONIAE 3992 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR SXT MIC RESULTS. ALL PANELS RETURNED THE ISOLATE RESULTS WITH THE EXPECTED RESISTANT (FOR S. PNEUMONIAE 3992) AND SUSCEPTIBLE (FOR S. PNEUMONIAE A49619) SXT MIC AND SIR RESULTS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. 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)#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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS PNEUMONIAE) HAD INCORRECT MIC RESULTS FOR THE DRUG TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP/SMX). THE USER COMPARED THE RESULTS TO AN OLDER PANEL AND KIRBY BAUER TESTING, RECEIVING DISCREPANT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 4.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREPTOCOCCUS PNEUMONIAE) HAD INCORRECT MIC RESULTS FOR THE DRUG TRIMETHOPRIM/SULFAMETHOXAZOLE (TMP/SMX). THE USER COMPARED THE RESULTS TO AN OLDER PANEL AND KIRBY BAUER TESTING, RECEIVING DISCREPANT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247069 BD PHOENIX¿ SMIC/ID-101 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5014275 30382904488025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown