BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCALIBUR¿ FLOW CYTOMETER

    MDR report key: 16273772 · Received January 31, 2023

    Report

    Report Number
    2916837-2023-00017
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 19, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903429752
    PMA / PMN Number
    K923790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BC
    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 2916837-2023-00017 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

    PMA / 510(K)#: K923790, K973483. INITIAL REPORTER PHONE #: (B)(6). 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

    IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS REULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH CELL ABSOLUTE COUNT IS REPORTED BY THE FSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS REULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH CELL ABSOLUTE COUNT IS REPORTED BY THE FSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051390 BD FACSCALIBUR¿ FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 342975 00382903429752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown