BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 19999132 · Received August 18, 2024

    Report

    Report Number
    1119779-2024-00616
    Event Type
    Malfunction
    Date Received
    August 18, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 31, 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
    CA, 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. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 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. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR NO MIC RESULTS FOR TRIMETHOPRIM / SULFAMETHOXAZOLE (SXT) WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT PROVIDE ISOLATES, PANEL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PANEL PHOENIX NMIC-311 A PATIENT ISOLATE GAVE NO MIC FOR THE DRUG TRIMETHOPRIM / SULFAMETHOXAZOLE (SXT). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045608 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