BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 14580363 · Received June 2, 2022

    Report

    Report Number
    1119779-2022-00802
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 21, 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
    JA
    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

    THIS COMPLAINT IS NO LONGER REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT INVOLVED IS NOT SOLD WITHIN THE US AND BD DOES NOT SELL A SIMILAR PRODUCT WITHIN THE US AND/OR IT IS NOT A REGISTERED MEDICAL DEVICE IN THE US. THE PREVIOUS MFR REPORT (B)(4) SHOULD BE CONSIDERED CANCELED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM THERE WAS MIS-IDENTIFICATION OF MICROORGANISMS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "MISMATCH BETWEEN PHOENIX 100 AND M50 MEASUREMENT RESULTS. DID THE FAILURE OCCUR WITH CONTROL OR PATIENT SAMPLES? PATIENT SAMPLE. WHAT WAS THE EXPECTED RESULT AND WHAT WAS THE RESULT OBTAINED BY THE CLIENT? S.AUREUS. WHAT IS THE MICROORGANISM? IT MIGHT BE S.AUREUS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM THERE WAS MIS-IDENTIFICATION OF MICROORGANISMS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "MISMATCH BETWEEN PHOENIX 100 AND M50 MEASUREMENT RESULTS DID THE FAILURE OCCUR WITH CONTROL OR PATIENT SAMPLES? => PATIENT SAMPLE WHAT WAS THE EXPECTED RESULT AND WHAT WAS THE RESULT OBTAINED BY THE CLIENT? => S.AUREUS WHAT IS THE MICROORGANISM? => IT MIGHT BE S.AUREUS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819256 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 443624 NA 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown