BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 18537516 · Received January 18, 2024

    Report

    Report Number
    1119779-2023-01510
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 16, 2023
    Report Date
    April 3, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486069
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR VANCOMYCIN (VA) WITH STAPHYLOCOCCUS AUREUS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 3192572. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES FOR THE INVESTIGATION. TO INVESTIGATE, FOUR RETENTION SAMPLES FROM COMPLAINT BATCH 3192572 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE S. AUREUS TO OBSERVE FOR VA MIC RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE S. AUREUS TO OBSERVE FOR VA MIC RESULTS. THE INVESTIGATION RETURNED ALL SIX PANELS WITH SATISFACTORY VA MIC RESULTS; THEREFORE THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON BATCH 3192572, NOT RELATED TO THIS DEFECT. 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: G.5: 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, K131331. 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 WHEN USING THE BD PHOENIX¿ PMIC/ID-106, A FALSE VANCOMYCIN RESISTANCE TO STAPH AUREUS WAS REPORTED FOR ONE (1) PATIENT SAMPLE. THE SAMPLE WAS SENT OUT TO A REFERENCE LAB AND VANCOMYCIN RESISTANCE WAS UNABLE TO BE CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX¿ PMIC ID-106, A FALSE VANCOMYCIN RESISTANCE TO STAPH AUREUS WAS REPORTED FOR ONE (1) PATIENT SAMPLE. THE SAMPLE WAS SENT OUT TO A REFERENCE LAB AND VANCOMYCIN RESISTANCE WAS UNABLE TO BE CONFIRMED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726621 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 3192572 30382904486069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown