BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST INDICATOR SOLUTION

    MDR report key: 14337994 · Received May 9, 2022

    Report

    Report Number
    1119779-2022-00671
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 12, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382902460047
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    AFTER FURTHER REVIEW, THIS COMPLAINT WAS FOUND TO BE FOR PANEL ABORT DUE TO INSUFFICIENT INDICATOR. THIS IS NOT A REPORTABLE EVENT; THEREFORE, THE MDR WILL BE CANCELLED. AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT # WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHOENIX¿ AST INDICATOR SOLUTION HAD AN INSUFFICIENT AMOUNT OF INDICATOR ON THE PANEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "PHOENIX ISSUES ¿INSUFFICIENT AMOUNT OF INDICATOR DETECTED ON PANEL¿ ALARM ON 5 PANELS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHOENIX¿ AST INDICATOR SOLUTION HAD AN INSUFFICIENT AMOUNT OF INDICATOR ON THE PANEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "PHOENIX ISSUES ¿INSUFFICIENT AMOUNT OF INDICATOR DETECTED ON PANEL¿ ALARM ON 5 PANELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744079 BD PHOENIX¿ AST INDICATOR SOLUTION SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 246004 1123280 30382902460047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown