BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ SMIC/ID-101

    MDR report key: 20463242 · Received October 16, 2024

    Report

    Report Number
    1119779-2024-00761
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 25, 2024
    Report Date
    September 26, 2024
    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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL SMIC/ID-101 (CATALOG NUMBER 448802) BATCH NUMBER 4156355. THE CUSTOMER DID NOT RETURN ISOLATES OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED PANEL RETURNS AND BINARY FILES FOR THE INVESTIGATION. IT WAS NOTED THAT THE CUSTOMER DETERMINED THAT THE ORGANISM IDENTIFICATIONS HAVE BEEN MANUALLY CHANGED BY THE LIS. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF 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. 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/ID-101 THE USER NOTED MISIDENTIFICATIONS OF RESULTS. FURTHER INVESTIGATION DETERMINED THAT THE PATIENT RESULTS WERE BEING ALTERED BY THE USER'S LABORATORY INFORMATION SYSTEM (LIS). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374820 BD PHOENIX¿ SMIC/ID-101 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4156355 30382904488025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown