BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 17195509 · Received June 23, 2023

    Report

    Report Number
    1119779-2023-00696
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 6, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    PMA / PMN Number
    K131331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 1119779-2023-00696 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

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. 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

    REPORT 3 OF 3 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM, E. COLI WAS MISIDENTIFIED AS CITROBACTER SPP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 NID MISIDENTIFICATION; NID RESULTS INCONGRUENT WITH COLONY MORPHOLOGY AND VITEK GN (INITIAL PHOENIX ID: CITROBACTER SPP, ACTUAL ID: E.COLI) CORRECTED REPORT, CUSTOMER REPORTED CITROBACTER WHEN ISOLATE WAS E.COLI; NO CHANGE IN PATIENT TREATMENT.

    Description of Event or Problem · 0

    REPORT 3 OF 3 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM, E. COLI WAS MISIDENTIFIED AS CITROBACTER SPP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 NID MISIDENTIFICATION; NID RESULTS INCONGRUENT WITH COLONY MORPHOLOGY AND VITEK GN (INITIAL PHOENIX ID: CITROBACTER SPP, ACTUAL ID: E.COLI) CORRECTED REPORT, CUSTOMER REPORTED CITROBACTER WHEN ISOLATE WAS E.COLI; NO CHANGE IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213803 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