BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 18420410 · Received December 29, 2023

    Report

    Report Number
    1119779-2023-01445
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    November 19, 2023
    Report Date
    February 15, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486069
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. PMA / 510K NUMBER: THE BD PHOENIX PMIC/ID-106 IS AN ANTIMICROBIAL RESISTANCE PANEL WHICH CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K131331, K020322, K021954, K022172, K023273, K023301, K024152, K030677, K031306, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K082538, K082852, K082913. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 3150521. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS, ISOLATES AND BINARY FILES BUT DID NOT RETURN PANELS FOR THE INVESTIGATION. THE CUSTOMER RETURNED LAB REPORTS SHOW PATIENT SAMPLES OF ENTEROCOCCUS FAECALIS IDENTIFIED AS ENTEROCOCCUS DURANS. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS S. PETTENKOFERI N-13 AND E. FAECALIS N-14. TO INVESTIGATE, TWO RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES S. PETTENKOFERI N-13 AND E. FAECALIS N-14 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. FAECALIS N-14 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE S. PETTENKOFERI N-13 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL SEVEN PANELS IDENTIFIED THEIR INOCULATED ISOLATE CORRECTLY , THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL CONFIRMED COMPLAINTS ON COMPLAINT BATCH 3150521. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ PMIC/ID-106, E. FAECALIS WAS MISIDENTIFIED AS E. DURANS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ PMIC/ID-106, E. FAECALIS WAS MISIDENTIFIED AS E. DURANS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245573 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 3150521 30382904486069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown