BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 24753003 · Received April 1, 2026

    Report

    Report Number
    1119779-2026-00593
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 9, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492923
    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, K022129, K023444, K023634, K023858, K024153, 031530, K031699, K031912, K032299, K032567, K032655, K032675, K033362, K033458, K033558, K033560, K041384, K042932, K052269, K060214, 060217, K060257, K060444, K060447, K061327, K061355, K061867, K062207, K062944, K063301, AND K06348. H4. DEVICE MANUFACTURE DATE: UNKNOWN INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR ERTAPENEM (ETP) WHEN USING PANEL PHOENIX NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER UNKNOWN. CUSTOMER RETURNED PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS WERE NOT AVAILABLE FOR THE INVESTIGATION. THE CUSTOMER NOTED THAT AP TUBING WAS INSTALLED INCORRECTLY, CAUSING CONTAMINATION AND FALSE RESISTANCE RESULTS. THE BATCH NUMBER WAS NOT PROVIDED, THEREFORE THIS COMPLAINT IS UNCONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. HISTORICAL TRENDING WAS REVIEWED AND THERE WERE NO TRENDS FOR HIGH MIC RESULTS FOR PANEL SKU 449292. BD 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-306 A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANT) FOR THE DRUG ERTAPENEM BUT WHEN REPEATED THE RESULT WAS SENSITIVE. THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING. IT IS ALSO TO BE NOTED THAT THE UPSTREAM INSTRUMENT WAS FOUND TO BE CONTAMINATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813455 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown