BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 18184394 · Received November 21, 2023

    Report

    Report Number
    1119779-2023-01263
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 25, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    00382904480073
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.4. MEDICAL DEVICE LOT #: 3202514. D.9. RETURNED TO MANUFACTURER ON: 20-NOV-2023. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.3. DEVICE EVAL BY MANUFACTURER? YES. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION OF SERRATIA MARCESCENS AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NID (CATALOG NUMBER 448007) BATCH NUMBER 3202514. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS, AN ISOLATE AND PANELS FOR THE INVESTIGATION. THE LAB REPORTS SHOW AN ISOLATE IDENTIFIED AS S. MARCESCENS AND E. CLOACAE WHEN USING THE COMPLAINT BATCH. THE ISOLATE WAS VERIFIED AS S. MARCESCENS WITH BRUKER MALDI BIOTYPER. TO INVESTIGATE, THREE CUSTOMER RETURNED PANELS FROM COMPLAINT BATCH 3202514 WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS U-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, TWO RETENTION PANELS FROM COMPLAINT BATCH 3202514 WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS U-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS U-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL SEVEN PANELS IDENTIFIED THE ISOLATE AS S. MARCESCENS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. WHILE THERE HAS BEEN AN OBSERVATION OF A PERFORMANCE FAILURE BY THE CUSTOMER, BD HAS NOT BEEN ABLE TO REPLICATE THE FAILURE THROUGH INVESTIGATIVE TESTING. AN OVERALL REVIEW OF GRAM NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON COMPLAINT BATCH 3202514, RELATED TO THIS DEFECT AND UNCONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT HAS BEEN REPORTED THAT WHILE USING THE BD PHOENIX¿ NID PANEL, A MISIDENTIFICATION WAS OBTAINED DURING USE. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT WHILE USING THE BD PHOENIX¿ NID PANEL, A MISIDENTIFICATION WAS OBTAINED DURING USE. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087921 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON, DICKINSON & CO. (SPARKS) 3202514 00382904480073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown