BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 15924176 · Received December 6, 2022

    Report

    Report Number
    1119779-2022-01450
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 19, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    PMA / PMN Number
    K131331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01450 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.

    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. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM MISIDENTIFICATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 CAN BE USED FOR DRUG SUSCEPTIBILITY, BUT CANNOT BE IDENTIFIED. IT IS CLINICALLY USED, AND THERE ARE DIFFERENCES AND COMPARATIVE TESTS. IT IS NOT A PROBLEM OF SLATS HAZARD, INJURY OR ERRONEOUS RESULTS? NO HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM MISIDENTIFICATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 CAN BE USED FOR DRUG SUSCEPTIBILITY, BUT CANNOT BE IDENTIFIED. IT IS CLINICALLY USED, AND THERE ARE DIFFERENCES AND COMPARATIVE TESTS. IT IS NOT A PROBLEM OF SLATS HAZARD, INJURY OR ERRONEOUS RESULTS? NO HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853484 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 443624 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown