BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANEL PHOENIX NMIC ID 304

    MDR report key: 10159615 · Received June 16, 2020

    Report

    Report Number
    1119779-2020-00142
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 23, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    LON
    UDI-DI
    30382904487431
    PMA / PMN Number
    K020321
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 6/8/2020 H.6. INVESTIGATION: THIS COMPLAINT IS FOR THE MIS-IDENTIFICATION OF KLEBSIELLA AEROGENES AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID 304 BATCH 0022657. THE CUSTOMER PROVIDED TWO ISOLATES FOR INVESTIGATION. NO PRODUCT RETURNS WERE PROVIDED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. THE FIRST ISOLATE PROVIDED BY THE CUSTOMER WAS TESTED ON FOUR RETENTION PANELS FROM THE COMPLAINT BATCH AND ONE PANEL FROM A SEPARATE BATCH. ALL TESTED PANELS YIELDED THE EXPECTED IDENTIFICATION RESULT OF K. AEROGENES. THE SECOND ISOLATE PROVIDED BY THE CUSTOMER WAS TESTED ON THREE RETENTION PANELS FROM THE COMPLAINT BATCH AND TWO PANELS FROM A SEPARATE BATCH. ALL PANELS TESTED WITH THIS ISOLATE YIELDED THE IDENTIFICATION RESULT OF ENTEROBACTER CLOACAE. TESTING OF INTERNAL AND ANY RETURNED MATERIAL PER THE PHOENIX¿ USER¿S MANUAL CONFIRMED DISCREPANT RESULTS. THE FREQUENCY OF THIS COMPLAINT HAS BEEN ASSESSED AND HAS BEEN DETERMINED TO FALL BELOW THE THRESHOLD LEVEL OF AN ACTIONABLE TREND. BD WILL CONTINUE TO MONITOR ALL COMPLAINTS AND TAKE APPROPRIATE ACTION SHOULD THE LEVEL EXCEED REQUIRED THRESHOLDS. FOR ALL COMPLAINTS RELATED TO IDENTIFICATION, BD PROVIDES THE FOLLOWING LIST OF PARAMETERS THAT OPTIMIZE LABORATORY RESULTS: QC TESTING SHOULD ONLY BE PERFORMED ON 2ND PASS SUBCULTURES AND AVOID USING COLONIES THAT HAVE BEEN SUB-CULTURED MULTIPLE TIMES. ISOLATED COLONIES ARE TO BE USED FOR INOCULATION AND CAREFULLY CHECK PURITY PLATES TO ENSURE THE INOCULUM CONSISTED OF ONE ISOLATE TYPE. OPTIMUM PERFORMANCE COMES FROM USING FRESH 18-24 HOUR, WELL-ISOLATED COLONIES ENSURE PROPER, SUFFICIENT INOCULUM DENSITY. ALLOW BUBBLES TO DISSIPATE AFTER VORTEXING . PROPERLY CALIBRATE THE BD PHOENIXSPEC¿ NEPHELOMETER WITH IN-DATE MCFARLAND CALIBRATION STANDARDS . USE SWABS WITH MINIMAL FIBER SHED . MAKE THE PROPER INOCULUM DENSITY FOR THE INOCULUM SYSTEM SETTING (I.E., IF PREPARING A 0.25 MCFARLAND INOCULUM, ENSURE THAT THE SYSTEM IS SET TO 0.5 INOCULUM MODE) VOLUME OF ID BROTH SHOULD BE VISUALLY ASSESSED FOR ANY OBVIOUS LOW FILLS ENSURE PROPER INCUBATION TEMPERATURE AND ENVIRONMENT USE THE CORRECT MEDIA TYPE AS LISTED AS ACCEPTABLE FOR USE IN THE USER¿S MANUAL (NOTE - IT IS HELPFUL TO DISCLOSE THE MEDIA TYPE AND VENDOR WHEN PROVIDING THE DETAILS OF THE COMPLAINT) . HANDLE PANELS BY ONLY TOUCHING THE SIDES; TOUCHING THE FRONT OR BACK OF THE PANELS MAY CAUSE INTERFERENCE IN THE READINGS AND LEAD TO ERRORS FOLLOW USER¿S MANUAL INSTRUCTIONS FOR TIME LIMITS ON POURING INOCULATED ID BROTH INTO THE PANEL AND PLACING THE PANEL INTO THE INSTRUMENT; EXTENDED PERIODS OF TIME OUTSIDE OF THE STATED LIMITATIONS MAY YIELD ERRORS ROOT CAUSE WAS NOT DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE PANEL PHOENIX NMIC ID 304, AN ERRONEOUS RESULTS WAS REPORTED. THE PANEL USED, MISIDENTIFIED KLEBSIELLA AEROGENES AS ENTEROBACTER CLOACAE. PATIENT RESULTS WERE REPORTED AND THE PATIENT RECEIVED TREATMENT. CONFIRMATORY TESTING WAS PERFORMED AND A CORRECTED REPORT WAS SENT TO THE PHYSICIAN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510K NUMBER: K040099, K131331. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE PANEL PHOENIX NMIC ID 304, AN ERRONEOUS RESULTS WAS REPORTED. THE PANEL USED, MISIDENTIFIED KLEBSIELLA AEROGENES AS ENTEROBACTER CLOACAE. PATIENT RESULTS WERE REPORTED AND THE PATIENT RECEIVED TREATMENT. CONFIRMATORY TESTING WAS PERFORMED AND A CORRECTED REPORT WAS SENT TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623111 PANEL PHOENIX NMIC ID 304 IDENTIFICATION/SUSCEPTIBILITY LON BECTON, DICKINSON & CO. 448743 0022657 30382904487431

    Patients

    Seq Age Sex Outcome Treatment
    1 Other