BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVIA FLOW CYTOMETER

    MDR report key: 10860354 · Received November 18, 2020

    Report

    Report Number
    2916837-2020-00262
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 15, 2020
    Report Date
    June 24, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906568748
    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

    INVESTIGATION SUMMARY: THE SERVICE INVESTIGATION WAS REVIEWED, AND NO FURTHER INVESTIGATION IS REQUIRED. BASED ON THE EVALUATION IT WAS DETERMINED THAT NO COMPLAINT HISTORY REVIEW AND NO ADDITIONAL CORRECTION IS REQUIRED AT THIS TIME. DCHU HAS REVIEWED THE COMPLAINT AND NO ADVERSE EVENT HAS OCCURRED AT THIS TIME. THIS COMPLAINT MODE WILL BE TRENDED, AND FURTHER INVESTIGATION WILL BE REQUIRED IF AN ACTIONABLE LEVEL IS DETERMINED DURING QUARTERLY POST MARKET SURVEILLANCE (PMS) REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD FACSVIA¿ FLOW CYTOMETER THERE WERE ERRONEOUS POPULATION RESULTS ON PATIENT SAMPLES THERE WAS NO PATIENT IMPACT. THE APPLICATION SPECIALIST REPORTS THAT THE CUSTOMER ENCOUNTERED A PROBLEM WHILE ANALYZING AN IMK ASSAY. THE CLIENT NOTED THAT THE CD8 + POPULATION IS NOT DETECTED DUE TO AN INCORRECT COMPENSATION BETWEEN APC AND PE. THE APP SPECIALIST TESTED THE REAGENTS ON ANOTHER INSTRUMENT BUT WITHOUT ENCOUNTERING THE SAME PROBLEM. ADDITIONALLY, ON 2020-11-10 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? N/A 6. WHAT IS THE CURRENT MEDICAL STATUS? N/A

    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 A BD FACSVIA¿ FLOW CYTOMETER THERE WERE ERRONEOUS POPULATION RESULTS ON PATIENT SAMPLES THERE WAS NO PATIENT IMPACT. THE APPLICATION SPECIALIST REPORTS THAT THE CUSTOMER ENCOUNTERED A PROBLEM WHILE ANALYZING AN IMK ASSAY. THE CLIENT NOTED THAT THE CD8 + POPULATION IS NOT DETECTED DUE TO AN INCORRECT COMPENSATION BETWEEN APC AND PE. THE APP SPECIALIST TESTED THE REAGENTS ON ANOTHER INSTRUMENT, BUT WITHOUT ENCOUNTERING THE SAME PROBLEM. ADDITIONALLY, ON 2020-11-10, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? N/A. WHAT IS THE CURRENT MEDICAL STATUS? N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325283 BD FACSVIA FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS & ACCESS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA 00382906568748

    Patients

    Seq Age Sex Outcome Treatment
    1