BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 18640201 · Received February 5, 2024

    Report

    Report Number
    1119779-2024-00073
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 10, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    SEE H10
    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

    G.5. PMA/510(K)#: THE PANEL PHOENIX NMIC/ID-311 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K123404, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932 H.3. 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

    H.6 INVESTIGATION SUMMARY : THIS COMPLAINT IS FOR HIGH MIC RESULTS WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 3311761. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS OR LAB REPORTS BUT PROVIDED ISOLATES AND LOG FILES FOR THE INVESTIGATION. TO INVESTIGATE, ONE RETENTION SAMPLE FROM COMPLAINT BATCH 3311761 WAS INOCULATED WITH CUSTOMER RETURNED ISOLATE ESCHERICHIA COLI #646 TO OBSERVE FOR MIC RESULTS. NEXT, TWO RETENTION SAMPLES EACH FROM COMPLAINT BATCH 3311761 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI #984 AND E. COLI #915 TO OBSERVE FOR MIC RESULTS. LAST, ONE RETENTION PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI #646, E. COLI # 984, AND E. COLI # 915. THE INVESTIGATION RETURNED ALL EIGHT PANELS WITH SATISFACTORY MIC RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. FOR FURTHER INVESTIGATION, THE BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON BATCH 3311761. 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 WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT ISOLATE WAS RESISTANT FOR CARBAPENEMS, BUT WHEN RETESTED USING ETEST OR ANOTHER PHOENIX PANEL THE RESULT WAS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT ISOLATE WAS RESISTANT FOR CARBAPENEMS, BUT WHEN RETESTED USING ETEST OR ANOTHER PHOENIX PANEL THE RESULT WAS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622499 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3311761 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown