BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 20322822 · Received September 27, 2024

    Report

    Report Number
    1119779-2024-00693
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 18, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486069
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 3353080. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND PHOTOS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW AN ISOLATE IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS. THE PHOTOS SHOW THE SEQUENCE NUMBERS AND DATES. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING IN HOUSE AND QC ISOLATES S. AUREUS A25923, S. AUREUS A29213, S. AUREUS 4757 AND S. AUREUS A43300 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH QC ISOLATE S. AUREUS A29213 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THE ISOLATES AS S. AUREUS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020322, K021954, K022172, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050555, K051689, K053241, K060214, K060217, K060218, K060218, K060493, K082538, K082852, K082913, AND K131331. 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 BD PHOENIX¿ PMIC/ID-106 THE USER EXPERIENCED MISIDENTIFICATIONS WITH STAPHYLOCOCCUS SPECIES FROM A PATIENT WOUND SPECIMEN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-106 THE USER EXPERIENCED MISIDENTIFICATIONS WITH STAPHYLOCOCCUS SPECIES FROM A PATIENT WOUND SPECIMEN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685133 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 3353080 30382904486069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown