BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-307

    MDR report key: 20183779 · Received September 10, 2024

    Report

    Report Number
    1119779-2024-00664
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492830
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN LOT NUMBER: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. E1: INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. 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. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR ERTAPENEM WHEN USING PHOENIX PANEL NMIC-307 (CATALOG NUMBER 449283) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT RETURN PHOENIX GENERATED LAB REPORTS, PANELS OR ISOLATES 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. 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 PANEL NMIC-307 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAVE FALSE RESISTANCE (HIGH MIC) FOR THE DRUG ERTAPENEM. THE USER VERIFIED THE PATIENT RESULTS WITH E-TEST STRIP PRIOR TO RELEASING TO PROVIDERS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-307 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAVE FALSE RESISTANCE (HIGH MIC) FOR THE DRUG ERTAPENEM. THE USER VERIFIED THE PATIENT RESULTS WITH E-TEST STRIP PRIOR TO RELEASING TO PROVIDERS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223736 BD PHOENIX PANEL NMIC-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382904492830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown