BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 16130481 · Received January 10, 2023

    Report

    Report Number
    1119779-2023-00009
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 14, 2022
    Report Date
    April 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: A1. PATIENT IDENTIFIER: (B)(6). B3. DATE OF EVENT: 14-DEC-2022. B5: DESCRIBE EVENT: REPORT 4 OF 7. IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS HAS OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF E. COLI WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBERS 2200759 AND 2235337. THE CUSTOMER PROVIDED PANEL RETURNS AND ISOLATE RETURNS BUT DID NOT PROVIDE LAB REPORTS FOR THE INVESTIGATION. IT IS TO BE NOTED THAT THE CUSTOMER ISOLATE WAS NOT VIABLE FOR INVESTIGATION TESTING AND QC ISOLATES WERE USED INSTEAD. TO INVESTIGATE, TWO (2) CUSTOMER RETURNED PANELS FROM COMPLAINT BATCH 2235337 WERE TESTED USING QC ISOLATES OF E. COLI A35218 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, THREE (3) CUSTOMER RETURNED PANELS FROM COMPLAINT BATCH 2235337 WERE TESTED USING QC ISOLATES OF E. COLI A25922 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, THREE (3) RETENTION PANELS FROM COMPLAINT BATCH 2200759 WERE TESTED USING QC ISOLATES OF E. COLI A25922 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. FOR A TOTAL OF EIGHT (8) PANELS TESTED, ALL RETURNED AN E. COLI IDENTIFICATION, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. BD ENCOURAGES YOU TO CONSIDER THE FOLLOWING PARAMETERS TO OPTIMIZE RESULTS WITHIN YOUR LABORATORY. 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 H3 OTHER TEXT : SEE H.10.

    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. PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 0

    REPORT 4 OF 7. IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS HAS OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS.

    Description of Event or Problem · 0

    REPORT 4 OF 10. IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS HAS OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS.

    Description of Event or Problem · 0

    REPORT 4 OF 10 IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS HAS OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISIDENTIFICATION OF E COLI AS OTHER GRAM NEGATIVE ORGANISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255988 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 449289 2235337 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown