BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 19335778 · Received May 16, 2024

    Report

    Report Number
    1119779-2024-00384
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR LOW MIC WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT PROVIDE PRODUCT RETURNS, ISOLATE RETURNS OR PHOENIX GENERATED LAB REPORTS 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: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. 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, K132674, K132909, K151320, K181665, 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 PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD DISCREPANT MICS. THE USER TESTED THE ISOLATE TWICE AND IT GAVE THE SAME RESULTS WHILE USING THE PANEL. THE ISOLATE WAS SENT TO THE STATE, AND THE RESULTS WERE DIFFERENT FROM THE PANEL RESULTS. ISOLATE WAS THEN REPEATED FROM THE SAVED ISOLATE, AND THEY WERE DIFFERENT AGAIN. THE FIRST TWO TIMES THE PANEL WAS RAN, THE PANEL GAVE A RESISTANT RESULT FOR MEROPENEM, AND THE STATE WAS RESISTANT. THE PANEL RESULT FOR PIPERACILLIN/TAZOBACTAM WAS INTERMEDIATE, BUT THE STATE RESULT WAS RESISTANT. THE THIRD REPEAT WITH THE PANEL CALLED CEFTAZIDIME/AVIBACTAM SENSITIVE, BUT THE STATE WAS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD DISCREPANT MICS. THE USER TESTED THE ISOLATE TWICE AND IT GAVE THE SAME RESULTS WHILE USING THE PANEL. THE ISOLATE WAS SENT TO THE STATE, AND THE RESULTS WERE DIFFERENT FROM THE PANEL RESULTS. ISOLATE WAS THEN REPEATED FROM THE SAVED ISOLATE, AND THEY WERE DIFFERENT AGAIN. THE FIRST TWO TIMES THE PANEL WAS RAN, THE PANEL GAVE A RESISTANT RESULT FOR MEROPENEM, AND THE STATE WAS RESISTANT. THE PANEL RESULT FOR PIPERACILLIN/TAZOBACTAM WAS INTERMEDIATE, BUT THE STATE RESULT WAS RESISTANT. THE THIRD REPEAT WITH THE PANEL CALLED CEFTAZIDIME/AVIBACTAM SENSITIVE, BUT THE STATE WAS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454730 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown