BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 20528650 · Received October 24, 2024

    Report

    Report Number
    1119779-2024-00780
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 27, 2024
    Report Date
    November 4, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 18-OCT-2024. INVESTIGATION SUMMARY THIS COMPLAINT IS FOR HIGH MIC VANCOMYCIN (VA) WITH STAPHYLOCOCCUS AUREUS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 4121401. THE CUSTOMER RETURNED PANELS, ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE PHOENIX GENERATED LAB REPORTS SHOW HIGH MIC VA RESULTS WITH S. AUREUS WHEN USING COMPLAINT BATCH 4121401. TO INVESTIGATE, RETENTION PANELS AND CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES S. AUREUS 71485, S. AUREUS 79383 AND S. AUREUS 79395 ON A PHOENIX M50 MACHINE AND EVALUATED FOR VA MIC RESULTS. ADDITIONALLY, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES S. AUREUS 71485, S. AUREUS 79383 AND S. AUREUS 79395 ON A PHOENIX M50 MACHINE AND EVALUATED FOR VA MIC RESULTS. ALL PANELS RETURNED EXPECTED VA MIC RESULTS, THEREFORE THIS COMPLAINT IS UNCONFIRMED. THE BATCH HISTORY RECORDS WERE 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 A PATIENT ISOLATE (S. AUREUS) FROM A WOUND SPECIMEN HAD A HIGH MIC FOR THE DRUG VANCOMYCIN. 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 A PATIENT ISOLATE (S. AUREUS) FROM A WOUND SPECIMEN HAD A HIGH MIC FOR THE DRUG VANCOMYCIN. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566302 BD PHOENIX¿ PMIC/ID-106 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4121401 30382904486069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown