BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC-307

    MDR report key: 11572692 · Received March 25, 2021

    Report

    Report Number
    1119779-2021-00558
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    K032299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THIS COMPLAINT IS DUE TO INCONSISTENT RESULTS OF CPO WHEN USING PHOENIX PANEL NMIC 307 (449283) BATCH 0210423. LAB RESULT REPORTS WERE PROVIDED BUT NO PRODUCT RETURNS OR ISOLATES WERE PROVIDED FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF THREE (3) RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING A PHOENIX M50 INSTRUMENT. TWO (2) PANELS WERE TESTED USING A QC ISOLATE OF KLEBSIELLA PNEUMONIAE (14780), AND YIELDED THE CORRECT MICS AND CARBAPENEMASE RESISTANCE MARKER (POSITIVE). ONE (1) PANEL WAS TEST USING AN IN HOUSE ISOLATE OF PSEUDOMONAS AERUGINOSA 17925, AND YIELDED THE CORRECT MICS AND CARBAPENEMASE RESISTANCE MARKER (POSITIVE). THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH.COMPLAINT TRENDING WAS PERFORMED AND A TREND WAS IDENTIFIED FOR THIS DEFECT IN JULY 2020. BASED ON THE SEVERITY AND RATE OF THE DEFECT, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS NOT INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-307 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ETEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-307 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ETEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468578 PANEL PHOENIX NMIC-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 0210423

    Patients

    Seq Age Sex Outcome Treatment
    1