BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 20965293 · Received December 18, 2024

    Report

    Report Number
    1119779-2024-01012
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 28, 2024
    Report Date
    March 20, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    K181665
    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 FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES. D10. RETURNED TO MANUFACTURER ON: 12-DEC-2024. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY : THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4233325. THE CUSTOMER RETURNED PANELS, ISOLATES, PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW MISIDENTIFICATIONS OF ACINETOBACTER BAUMANNII AS CEDECEA LAPAGEI, ENTEROBACTER CLOACAE AS KLUYVERA INTERMEDIA, KLEBSIELLA PNEUMONIAE AS ENTEROBACTER CLOACAE, SERRATIA MARCESCENS AS CEDECEA DAVISAE, ENTEROBACTER CLOACAE AS CITROBACTER FREUNDII, ESCHERICHIA COLI AS SHIGELLA DYSENTERIAE, PROTEUS MIRABILIS AS PROVIDENCIA RETTGERI AND KLEBSIELLA PNEUMONIAE AS ENTEROBACTER CLOACAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22, S. MARCESCENS UPMC-23, E. HORMAECHEI UPMC-25, E. COLI UPMC-26, P. MIRABILIS UPMC-27 AND E. HORMAECHEI UPMC-28. TO INVESTIGATE, CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22 AND S. MARCESCENS UPMC-23 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22, S. MARCESCENS UPMC-23, E. HORMAECHEI UPMC-25, E. COLI UPMC-26, P. MIRABILIS UPMC-27 AND E. HORMAECHEI UPMC-28 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES S. MARCESCENS UPMC-23, E. HORMAECHEI UPMC-25, E. COLI UPMC-26 AND P. MIRABILIS UPMC-27 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATES A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22, E. HORMAECHEI UPMC-25, P. MIRABILIS UPMC-27 AND E. HORMAECHEI UPMC-28 IDENTIFIED THEIR RESPECTIVE ISOLATES CORRECTLY. ALL PANELS TESTED WITH CUSTOMER RETURNED ISOLATES S. MARCESCENS UPMC-23, E. COLI UPMC-26 AND E. HORMAECHEI UPMC-28 RETURNED MISIDENTIFICATION RESULTS, THEREFORE, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. AS PART OF THE INVESTIGATION, BD R&D PERFORMED AN ANALYSIS OF THE CUSTOMER BINARY FILES. REVIEW OF THE BINARY FILES FROM THE CUSTOMER'S INTERNAL TESTING SHOWS VARIABILITY IN SOME OF THE SUBSTRATE REACTIONS. REVIEW OF THE FILES SHOWS THAT SOME OF THE SUBSTRATE REACTIONS WERE MORE ALIGNED WITH A SHIGELLA DYSENTERIAE IDENTIFICATION AS OPPOSED TO ESCHERICHIA COLI. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (SERRATIA MARCESCENS) WAS MISIDENTIFIED AS CEDECEA DAVISAE. REPEAT TESTING WAS PERFORMED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 4 OF 8.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (SERRATIA MARCESCENS) WAS MISIDENTIFIED AS CEDECEA DAVISAE. REPEAT TESTING WAS PERFORMED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 4 OF 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283394 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4233325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown