BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVIA¿ FLOW CYTOMETER

    MDR report key: 18377944 · Received December 21, 2023

    Report

    Report Number
    2916837-2023-00232
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 22, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00232 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED DURING USE WITH THE BD FACSVIA¿ FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST ? YES. 2. WAS THERE AN ERROR MESSAGE ? YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE ? YES. 4. IS THIS PRESTO ? NO. 656874 - BD FACSVIA FLOW CYTOMETER - THE CYTOMETER STOPPED BECAUSE BLUE LASER ERROR OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED DURING USE WITH THE BD FACSVIA¿ FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 ¿ ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST ? YES 2 ¿ WAS THERE AN ERROR MESSAGE ? YES 3- DID THE CUSTOMER BYPASS THE ERROR MESSAGE ? YES 4 ¿ IS THIS PRESTO ? NO 656874 - BD FACSVIA FLOW CYTOMETER - THE CYTOMETER STOPPED BECAUSE BLUE LASER ERROR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306026 BD FACSVIA¿ FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS AND ACCS OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown