BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC ID 406

    MDR report key: 12845356 · Received November 19, 2021

    Report

    Report Number
    1119779-2021-01865
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    September 3, 2021
    Report Date
    May 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    K023634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE PHOENIX PANEL NMIC/ID-307 CATALOG NUMBER 449289 WHICH HAS MULTIPLE 510K NUMBERS. THE BD PHOENIX NMIC-307 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: (K032299, K061355, K023444, K063824, 033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K063811, K151320, K063301, K031530, K060447, , K023634, K020322, K132674, K023858, K071623, K031699, K060447, K024153, K060214, K042932.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 16-NOV-2021. H.6. INVESTIGATION: THIS COMPLAINT IS FOR MISIDENTIFICATION OF PSEUDOMONAS AERUGINOSA AS ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC/ID-406 (448748) BATCH NUMBER 1089733. THE CUSTOMER DID RETURN PANELS AND LAB REPORTS FOR INVESTIGATION, HOWEVER DID NOT RETURN ISOLATES. TO INVESTIGATE, A TOTAL OF THREE (3) CUSTOMER RETURNED PANELS WERE TESTED USING BD ISOLATES OF PSEUDOMONAS AERUGINOSA: A27853, A35032, AND 11052. ONE PANEL WAS TESTED PER ISOLATE ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL THREE PANELS TESTED IDENTIFIED CORRECTLY AS PSEUDOMONAS AERUGINOSA. SINCE ALL PANELS YIELDED SATISFACTORY IDENTIFICATION RESULTS, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS FOR THE 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE PHOENIX PANEL NMIC/ID (B)(4) CATALOG NUMBER 449289 WHICH HAS MULTIPLE 510K NUMBERS. THE BD PHOENIX NMIC(B)(4) IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC ID 406 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " INCONSISTENT GN PANEL RESULTS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC ID 406 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " INCONSISTENT GN PANEL RESULTS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC ID (B)(4) ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " INCONSISTENT GN PANEL RESULTS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742470 PANEL PHOENIX NMIC ID 406 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 1089733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown