BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVIA FLOW CYTOMETER

    MDR report key: 10808822 · Received November 9, 2020

    Report

    Report Number
    2916837-2020-00236
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 20, 2020
    Report Date
    June 23, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSVIA¿ FLOW CYTOMETER THERE WAS AN EXTRA POPULATION ON PATIENT SAMPLE. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: APPLICATION SPECIALIST REPORT THAT THE CLIENT ENCOUNTERED A PROBLEM WHILE ANALYZING AN IMK ASSAY. THE EXTRA POPULATION THAT THE CUSTOMER NOTICES IS DUE TO AN INCORRECT COMPENSATION BETWEEN PERCP AND PE. BY INCREASING THE COMPENSATION FROM 1.53% TO 20%, THE PROBLEM DISAPPEARS. :"ERRONEOUS RESULTS WERE ON PATIENT SAMPLES BUT THE OPERATOR REALIZED THAT THE RESULT WAS INCORRECT AND DID NOT USE THE ERRONEOUS RESULT FOR DIAGNOSIS OR TREATMENT. NO HARM TO THE PATIENT DERIVED FROM THE ERRONEOUS RESULT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH BD FACSVIA FLOW CYTOMETER THERE WAS AN EXTRA POPULATION ON PATIENT SAMPLE. RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: APPLICATION SPECIALIST REPORT THAT THE CLIENT ENCOUNTERED A PROBLEM WHILE ANALYZING AN IMK ASSAY. THE EXTRA POPULATION THAT THE CUSTOMER NOTICES IS DUE TO AN INCORRECT COMPENSATION BETWEEN PERCP AND PE. BY INCREASING THE COMPENSATION FROM 1.53% TO 20%, THE PROBLEM DISAPPEARS. "ERRONEOUS RESULTS WERE ON PATIENT SAMPLES BUT THE OPERATOR REALIZED THAT THE RESULT WAS INCORRECT AND DID NOT USE THE ERRONEOUS RESULT FOR DIAGNOSIS OR TREATMENT. NO HARM TO THE PATIENT DERIVED FROM THE ERRONEOUS RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278879 BD FACSVIA FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS & ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1