BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 14104807 · Received April 13, 2022

    Report

    Report Number
    1119779-2022-00557
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 15, 2022
    Report Date
    December 14, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K032299, K071623, K062207 AND K032655. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR INCORRECT BREAKPOINTS WHEN USING PHOENIX PANEL NMIC-311 (449452) BATCH 2005696. CUSTOMER IS REPORTING A DIFFERENCE IN BREAK POINTS BETWEEN URINE AND BLOOD ON FOUR ANTIMICROBIALS. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, OR ISOLATE RETURNS BUT DID SUBMIT LAB REPORTS FOR THE INVESTIGATION. SUBSEQUENT FOLLOW UP BY TECH SERVICES WITH THE CUSTOMER INDICATES THAT THE CUSTOMER "PERFORMED MANUAL TESTING / DISK DIFFUSION AND THAT THE RESULTS UPHELD THE PHOENIX RESULTS. WHILE THE BEHAVIOR OF THIS PARTICULAR ORGANISM IS PECULIAR THE CUSTOMER DOES NOT WISH TO EXPLORE THE MATTER ANY FURTHER AS SUCH THERE ARE NO FURTHER ACTIONS TO BE TAKEN". BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THE PANEL BATCH IN QUESTION IS NOT CONSIDERED TO BE DEFECTIVE. THEREFORE, COMPLAINT IS NOT CONFIRMED. FOR FURTHER REVIEW, A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 1.0-1.15, INDICATES THE POTENTIAL RISK OF A FALSE SUSCEPTIBLE RESULT WAS ASSESSED AS S4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC-311 THERE WAS A DIFFERENCE IN BREAK POINTS BETWEEN URINE AND BLOOD ON 4 ANTIMICROMIALS. ANTIMICROBIALS USED ARE AMPICILLIN, AMPICILLIN SULBACTEM, CEFTIZOXIME AND CEFTRIAXONE. THIS OCCURRED TWICE. THERE WERE NO REPORTED RESULTS OF CONFIRMATORY TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A DIFFERENCE IN BREAK POINTS BETWEEN URINE AND BLOOD ON FOUR ANTIMICROBIALS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC-311 THERE WAS A DIFFERENCE IN BREAK POINTS BETWEEN URINE AND BLOOD ON 4 ANTIMICROMIALS. ANTIMICROBIALS USED ARE AMPICILLIN, AMPICILLIN SULBACTEM, CEFTIZOXIME AND CEFTRIAXONE. THIS OCCURRED TWICE. THERE WERE NO REPORTED RESULTS OF CONFIRMATORY TESTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A DIFFERENCE IN BREAK POINTS BETWEEN URINE AND BLOOD ON FOUR ANTIMICROBIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563558 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 2005696

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown