BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-308

    MDR report key: 12124438 · Received July 6, 2021

    Report

    Report Number
    1119779-2021-01126
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR FALSE NEGATIVE RESULTS WHEN USING PHOENIX PANEL NMIC/ID-308 (449282) BATCH NUMBER 1005065. THE CUSTOMER DID NOT RETURN LAB REPORTS, PANELS, OR ISOLATES FOR INVESTIGATION. THE CUSTOMER STATED THAT THE ISOLATE DID NOT FLAG AS ESBL AND ALSO DID NOT FLAG CPO EVEN THOUGH THE ISOLATE WAS RESISTANT TO ERTAPENEM AND MEROPENEM. TO INVESTIGATE, A TOTAL OF FOUR RETENTION PANELS FROM THE SAME CATALOG NUMBER BUT DIFFERENT BATCH AS THE COMPLAINT BATCH DUE TO THE COMPLAINT BATCH BEING EXPIRED AT THE TIME OF INVESTIGATION WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI (A25922) AND IN HOUSE ISOLATES OF KLEBSIELLA PNEUMONIAE (ENF14780) ON A PHOENIX INSTRUMENT AND EVALUATED FOR CPO RESULTS, ESBL RESULTS, AND ERTAPENEM AND MEROPENEM MIC RESULTS. TWO PANELS WERE TESTED PER ISOLATE. DURING INVESTIGATION, THE TWO PANELS TESTED USING QC ISOLATES OF ESCHERICHIA COLI (A25922) YIELDED SATISFACTORY MIC RESULTS FOR ERTAPENEM AND MEROPENEM AND BOTH PANELS RESULTED IN CPO NEGATIVE AND ESBL NEGATIVE WHICH IS THE EXPECTED RESULT. THE TWO PANELS TESTED USING IN HOUSE ISOLATES OF KLEBSIELLA PNEUMONIAE (ENF14780) YIELDED SATISFACTORY MIC RESULTS FOR ERTAPENEM AND MEROPENEM AND BOTH PANELS RESULTED IN CPO POSITIVE AND ESBL POSITIVE WHICH IS THE EXPECTED RESULT. DUE TO THE SATISFACTORY INVESTIGATION RESULTS, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THIS DEFECT. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 14.0-14.14, INDICATES THE POTENTIAL RISK OF A FALSE NEGATIVE CPO RESULTS AS S4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-308 FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A KIRBY BAUER TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT RESISTANCE MARKERS NOT FLAGGING. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE PANEL PHOENIX NMIC/ID-308 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K173252, K063811, K151320, K063301, K023634, K020322, K132674, K063486, K023858, K031699, K060447, K042932.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-308 FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A KIRBY BAUER TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT RESISTANCE MARKERS NOT FLAGGING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020318 PANEL PHOENIX NMIC/ID-308 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 1005065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown