BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC/ID-307

    MDR report key: 21868782 · Received April 18, 2025

    Report

    Report Number
    1119779-2025-00280
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    April 27, 2022
    Report Date
    April 16, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, K033458 AND K123266. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS SALMONELLA SPECIES WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 1355167. THE CUSTOMER DID RETURN ISOLATES, BUT DID NOT RETURN PANELS OR LAB REPORTS FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES OF ESCHERICHIA COLI (91813216) ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ONE PANEL IDENTIFIED CORRECTLY AS ESCHERICHIA COLI. THE OTHER TWO PANELS IDENTIFIED INCORRECTLY AS SHIGELLA BOYDII. ADDITIONALLY, MALDI TESTING WAS PERFORMED AND DID IDENTIFY THE ORGANISM AS ESCHERICHIA COLI. THIS COMPLAINT IS CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS A SALMONELLA SPECIES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29526 BD PHOENIX¿ NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 1355167 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown