BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-109

    MDR report key: 16908378 · Received May 10, 2023

    Report

    Report Number
    1119779-2023-00544
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    August 19, 2022
    Report Date
    June 2, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486090
    PMA / PMN Number
    K040716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 1119779-2023-00544 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.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ PMIC/ID-109 THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. WAS THERE ANY PATIENT IMPACT? (Y/N) N, THE TEST WAS REPEATED TO GIVE THE CORRECT RESULT TO PATIENTS. PHOENIX 448609 E. AVIUM NOT GROWING ON PANEL

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ PMIC/ID-109 THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. WAS THERE ANY PATIENT IMPACT? (Y/N) N, THE TEST WAS REPEATED TO GIVE THE CORRECT RESULT TO PATIENTS. PHOENIX 448609 E. AVIUM NOT GROWING ON PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688217 BD PHOENIX¿ PMIC/ID-109 SEE H.10 LON BECTON, DICKINSON & CO. (SPARKS) 448609 UNKNOWN 30382904486090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown