BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-308

    MDR report key: 11916950 · Received June 1, 2021

    Report

    Report Number
    1119779-2021-00934
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 5, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE BD 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR QC FAILURES DUE TO INVALID MIC RESULTS WHEN USING PHOENIX PANEL NMIC/ID-308 (449282) BATCH NUMBERS 0189031 AND 0231279. THE CUSTOMER DID NOT RETURN LAB REPORTS, ISOLATES, OR PANELS FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF EIGHT (8) RETENTION PANELS WERE TESTED, FOUR (4) FROM EACH COMPLAINT BATCH, USING A PHOENIX 100 INSTRUMENT. FOR EACH COMPLAINT BATCH, THE FOUR (4) PANELS WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI (A25922 & A35218), PSEUDOMONAS AERUGINOSA (A27853), AND KLEBSIELLA PNEUMONIAE (A700603). ONE PANEL WAS TESTED FOR EACH ISOLATE. ALL EIGHT (8) PANELS WERE EVALUATED FOR INVALID AST RESULTS OR ERRORS. DURING INVESTIGATION, ALL PANELS TESTED YIELDED SATISFACTORY RESULTS AND DID NOT YIELD ANY INVALID AST RESULTS OR ERRORS. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON EACH OF THE COMPLAINT BATCHES. 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-308 NO MIC RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CUSTOMER REPORTS INVALID AST PANELS AND ERRORS FOR PANELS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-308 NO MIC RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTS INVALID AST PANELS AND ERRORS FOR PANELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810297 PANEL PHOENIX NMIC/ID-308 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 0231279

    Patients

    Seq Age Sex Outcome Treatment
    1