BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC/ID-307

    MDR report key: 17982157 · Received October 21, 2023

    Report

    Report Number
    1119779-2023-01164
    Event Type
    Malfunction
    Date Received
    October 21, 2023
    Date of Event
    September 27, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 3213048. D.4. MEDICAL DEVICE EXPIRATION DATE: 29-JUL-2024. H.4. DEVICE MANUFACTURE DATE: 01-AUG-2023. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS CITROBACTER FERMERII OR ENTEROBACTER CLOACAE AND PROTEUS SPECIES AS PROVIDENCIA RETTGERI WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213048. THE CUSTOMER RETURNED ISOLATES AND PANELS BUT DID NOT RETURN PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED E. COLI TC-1 THROUGH TC-3 AND P. MIRABILIS TC-4. THE CUSTOMER RETURNED PANELS WERE NOT AVAILABLE AT THE TIME OF COMPLAINT INVESTIGATION. TO INVESTIGATE, TWO RETENTION PANELS EACH OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES E. COLI TC-1 THROUGH TC-3 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI TC-1 THROUGH TC-3 AND P. MIRABILIS TC-4 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, FOUR RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE P. MIRABILIS TC-4 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, TWO RETENTION PANELS OF THE COMPLAINT BATCH AND ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING QC ISOLATE P. MIRABILIS A29906 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL THIRTEEN PANELS OF THE COMPLAINT BATCH IDENTIFIED THEIR INOCULATED ISOLATE CORRECTLY. THE CONTROL PANELS RETURNED PASSING IDENTIFICATION RESULTS. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213048. 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.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD PANEL PHOENIX NMIC/ID-307 THERE IS MISIDENTIFICATION OF GRAM-NEGATIVE ORGANISMS. TESTING REPEATED AND CORRECT ORGANISM IS IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MIS-IDENTIFIED GRAM-NEGATIVE ORGANISMS FROM PRODUCT 449289. "ONE SPECIFIC EXAMPLE INCLUDES ESCHERICHIA COLI (INDOLE+) BEING IDENTIFIED AS EITHER ENTEROBACTER CLOACAE (INDOLE-) OR CITROBACTER FARMERI (INDOLE-), AND UPON REPEAT ANALYSIS WE'LL FINALLY GET THE RIGHT ORGANISM ID OF E. COLI. WE HAVE ALSO HAD ISSUES WITH PROTEUS SPECIES BEING IDENTIFIED AS PROVIDENCIA RETTGERI, WHERE REPEAT TESTING WILL EVENTUALLY LEAD TO THE CORRECT ID".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD PANEL PHOENIX NMIC/ID-307 THERE IS MISIDENTIFICATION OF GRAM-NEGATIVE ORGANISMS. TESTING REPEATED AND CORRECT ORGANISM IS IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MIS-IDENTIFIED GRAM-NEGATIVE ORGANISMS FROM PRODUCT 449289. "ONE SPECIFIC EXAMPLE INCLUDES ESCHERICHIA COLI (INDOLE+) BEING IDENTIFIED AS EITHER ENTEROBACTER CLOACAE (INDOLE-) OR CITROBACTER FARMERI (INDOLE-), AND UPON REPEAT ANALYSIS WE'LL FINALLY GET THE RIGHT ORGANISM ID OF E. COLI. WE HAVE ALSO HAD ISSUES WITH PROTEUS SPECIES BEING IDENTIFIED AS PROVIDENCIA RETTGERI, WHERE REPEAT TESTING WILL EVENTUALLY LEAD TO THE CORRECT ID ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996726 BD PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3213048 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown