BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 19661240 · Received July 2, 2024

    Report

    Report Number
    1119779-2024-00537
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 7, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC IMIPENEM (IPM) AND MEROPENEM (MEM) WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT PROVIDE PHOENIX GENERATED LAB REPORTS, ISOLATES OR PANEL RETURNS FOR THE INVESTIGATION. 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. A REVIEW OF COMPLAINTS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    UNKNOWN LOT NUMBER: D4: MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4: DEVICE MANUFACTURE DATE: UNKNOWN. G5. PMA/510(K)#: K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K123404, K132674, K132909, K151320, K173252, K190905, K163637, K173523, K033458, AND K123266. 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 PANEL PHOENIX NMIC-311AN UNSPECIFIED NUMBER OF THE ENTEROBACTERALES SPECIES HAVE HIGH MICS FOR THE DRUGS ERTAPENEM AND MEROPENEM FOR PATIENT ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PANEL PHOENIX NMIC-311AN UNSPECIFIED NUMBER OF THE ENTEROBACTERALES SPECIES HAVE HIGH MICS FOR THE DRUGS ERTAPENEM AND MEROPENEM FOR PATIENT ISOLATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760146 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown