BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 11952375 · Received June 7, 2021

    Report

    Report Number
    1119779-2021-00951
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE BD PHOENIX NMIC-305 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K023444, K063824, K033560, 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: MEDICAL DEVICE LOT #: 0356961 MEDICAL DEVICE EXPIRATION DATE: 1/31/2022 DEVICE MANUFACTURE DATE: 12/21/2020 INVESTIGATION: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS SALMONELLA WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 0356961. THE CUSTOMER DID RETURN ISOLATES AND LAB REPORTS FOR INVESTIGATION, HOWEVER DID NOT RETURN PANELS. TO INVESTIGATE, A TOTAL OF FOUR (4) RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES OF ESCHERICHIA COLI ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL FOUR (4) PANELS TESTED IDENTIFIED INCORRECTLY AS SALMONELLA ENTERICA SSP ARIZONAE. SINCE ALL PANELS YIELDED UNSATISFACTORY IDENTIFICATION RESULTS, THIS COMPLAINT IS CONFIRMED. IT IS TO BE NOTED THAT MALDI TESTING WAS ALSO PERFORMED ON THE CUSTOMER RETURNED ISOLATES AND YIELDED AN IDENTIFICATION OF ESCHERICHIA COLI. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE (1) ADDITIONAL COMPLAINT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 A MIS-ID 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: "CUSTOMER REPORTS MIS-ID OF E.COLI AS SALMONELLA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 A MIS-ID 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: "CUSTOMER REPORTS MIS-ID OF E.COLI AS SALMONELLA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848363 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 449289 0356961 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1