BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 13742018 · Received March 12, 2022

    Report

    Report Number
    1119779-2022-00424
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    February 15, 2022
    Report Date
    April 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 21-FEB-2022. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE RESISTANT RESULTS OF ERTAPENEM (ETP) WITH KLEBSIELLA PNEUMONIAE, CITROBACTER KOSERI, AND ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH 1153290. THE CUSTOMER DID PROVIDE ISOLATES AND PANEL RETURNS FOR INVESTIGATION. TO INVESTIGATE, SEVEN CUSTOMER RETURNED PANELS WERE TESTED USING THE CUSTOMER RETURNED ISOLATES ON A PHOENIX 100 INSTRUMENT AND EVALUATED FOR ERTAPENEM (ETP) RESULTS. ONE PANEL WAS TESTED USING THE CUSTOMER'S KLEBSIELLA PNEUMONIAE ISOLATE, ONE PANEL WAS TESTED USING THE CUSTOMER'S ISOLATE OF CITROBACTER KOSERI, AND ONE PANEL WAS TESTED PER EACH STRAIN OF ESCHERICHIA COLI (5) FOR A TOTAL OF SEVEN PANELS TESTED. DURING INVESTIGATION, ALL SEVEN PANELS YIELDED SATISFACTORY ERTAPENEM (ETP) RESULTS WITHIN THE SPECIFIED RANGES. DUE TO THE SATISFACTORY RESULTS, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THIS COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS FOR THIS COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    THE BD PHOENIX NMIC-306 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, K181665, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K032567, K060257, K023634, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932. 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 THAT WHILE TESTING WITH THE BD PHOENIX PANEL NMIC-306, ABOUT 10 FALSE RESISTANT RESULTS WERE OBTAINED. REPEAT TESTING WAS PERFORMED AND THE RESULTS WERE SENSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MIC DISCREPANCY (EXPECTED: ERTAPENEM INITIALLY REPORTING RESISTANT; ACTUAL: ERTAPENEM ARE REPEATING SUSCEPTIBLE. CUSTOMER REPORTS FALSE RESISTANCE WITH ERTAPENEM WHEN USING 449292 - LOT #1153290. ABOUT TEN SAMPLES WERE AFFECTED. INITIALLY THE P100 RESULTED ERTAPENEM AS RESISTANT BUT WERE FOUND TO BE SENSITIVE AFTER REPEATING ON THE SAME P100.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PHOENIX PANEL NMIC-306, ABOUT 10 FALSE RESISTANT RESULTS WERE OBTAINED. REPEAT TESTING WAS PERFORMED AND THE RESULTS WERE SENSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MIC DISCREPANCY (EXPECTED: ERTAPENEM INITIALLY REPORTING RESISTANT; ACTUAL: ERTAPENEM ARE REPEATING SUSCEPTIBLE CUSTOMER REPORTS FALSE RESISTANCE WITH ERTAPENEM WHEN USING 449292 - LOT #1153290. ABOUT TEN SAMPLES WERE AFFECTED. INITIALLY THE P100 RESULTED ERTAPENEM AS RESISTANT BUT WERE FOUND TO BE SENSITIVE AFTER REPEATING ON THE SAME P100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972630 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 1153290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown