BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AST-S INDICATOR SOLUTION

    MDR report key: 14958792 · Received July 8, 2022

    Report

    Report Number
    1119779-2022-00965
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 9, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382902460091
    PMA / PMN Number
    K050745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-00965 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX¿ AST-S INDICATOR SOLUTION A PERFORMANCE ISSUE OCCURRED. THIS OCCURRED 6 TIMES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ONE DROP OF ZHURONG AST INDICATOR IS PUT ON THE MACHINE, THE INSTRUMENT SHOWS THAT THE INDICATOR IS INSUFFICIENT, WHICH LEADS TO THE FAILURE OF THE ON-BOARD INTERPRETATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX¿ AST-S INDICATOR SOLUTION A PERFORMANCE ISSUE OCCURRED. THIS OCCURRED 6 TIMES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ONE DROP OF ZHURONG AST INDICATOR IS PUT ON THE MACHINE, THE INSTRUMENT SHOWS THAT THE INDICATOR IS INSUFFICIENT, WHICH LEADS TO THE FAILURE OF THE ON-BOARD INTERPRETATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844652 BD PHOENIX¿ AST-S INDICATOR SOLUTION SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 1251154 00382902460091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown