BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-106

    MDR report key: 17990978 · Received October 23, 2023

    Report

    Report Number
    1119779-2023-01169
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 14, 2023
    Report Date
    March 7, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486069
    PMA / PMN Number
    K020322
    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

    G5: PMA/510(K)#: 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 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING BD PHOENIX¿ PMIC/ID-106 THAT THERE WAS A FALSE RESISTANT RESULT REPORTED OUT ON ONE PATIENT. CUSTOMER IS UNABLE TO CONFIRM IF THERE WAS PATIENT IMPACT. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR VANCOMYCIN (VA) WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 3150521. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, ISOLATES OR LAB REPORTS BUT PROVIDED BINARY FILES FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION SAMPLES EACH FROM COMPLAINT BATCH 3150521 WERE INOCULATED WITH QC ISOLATES STAPHYLOCOCCUS AUREUS A29213 AND ENTEROCOCCUS FAECALIS A29212 TO OBSERVE FOR VA MIC RESULTS. THE INVESTIGATION RETURNED ALL SIX PANELS WITH SATISFACTORY VA MIC RESULTS, THEREFORE THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. FOR FURTHER INVESTIGATION, 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHOENIX¿ PMIC/ID-106 THAT THERE WAS AN INCORRECT VANCOMYCIN MIC RESULT REPORTED OUT ON ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING INCORRECT AST FOR PRODUCT 448606 LOT NO. 3150521. CUSTOMER INITIALLY RECEIVED A RESULT OF VAN MIC = 4 AND SIR OF INTERMEDIATE. CUSTOMER STATED THAT THEY RERAN THE PANEL TWICE AND MIC WAS = 1 AND SIR = SUSCEPTIBLE. INITIAL RUN WAS RELEASED TO THE CHART. AFTER FURTHER INVESTIGATION, CUSTOMER IS NOT ABLE TO CONFIRM IF PATIENT CARE WAS CHANGED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHOENIX¿ PMIC/ID-106 THAT THERE WAS A FALSE RESISTANT RESULT REPORTED OUT ON ONE PATIENT. CUSTOMER IS UNABLE TO CONFIRM IF THERE WAS PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949319 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