BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 13119280 · Received December 30, 2021

    Report

    Report Number
    1119779-2021-02064
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    November 18, 2021
    Report Date
    September 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BD PHOENIX NMIC-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT 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. 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 MISIDENTIFICATION OF E. CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 1251384. THE CUSTOMER DID PROVIDE LAB REPORTS, BUT DID NOT PROVIDE ISOLATES OR PANELS FOR INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED ON A PHOENIX M50 INSTRUMENT USING QC ISOLATES OF ENTEROBACTER CLOACAE (11061), AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION, ALL PANELS IDENTIFIED CORRECTLY. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH PANEL PHOENIX NMIC/ID-307, A SPECIMEN WAS IDENTIFIED INCORRECTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED AN ORGANISM WAS MISIDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH PANEL PHOENIX NMIC/ID-307, A SPECIMEN WAS IDENTIFIED INCORRECTLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED AN ORGANISM WAS MISIDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018185 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 449289 1251384 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown