BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 18183090 · Received November 21, 2023

    Report

    Report Number
    1119779-2023-01260
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 27, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904486068
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 24-OCT-2023 H6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS EPIDERMIDIS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 3150521. THE CUSTOMER DID NOT RETURN PHOENIX GENERATED LAB REPORTS BUT PROVIDED BINARY FILES, AN ISOLATE AND PANELS UNDER CASE NUMBER (B)(6)FOR THE INVESTIGATION. THE ISOLATE WAS VERIFIED AS S. AUREUS WITH BRUKER MALDI BIOTYPER. TO INVESTIGATE, TWO CUSTOMER RETURNED PANELS FROM COMPLAINT BATCH 3150521 WAS TESTED USING CUSTOMER RETURNED ISOLATE S. AUREUS SJ-4 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE TWO PANELS IDENTIFIED THE ISOLATE AS S. AUREUS, 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. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED FIVE ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3150521, ONE OF WHICH IS 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. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: 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. 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 WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-106 STAPHYLOCOCCUS AUREUS WAS MISIDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS ON ONE PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-106 STAPHYLOCOCCUS AUREUS WAS MISIDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS ON ONE PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854837 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 3150521 00382904486068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown