BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LEUCOCOUNT

    MDR report key: 11834657 · Received May 17, 2021

    Report

    Report Number
    2916837-2021-00239
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 23, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903410033
    PMA / PMN Number
    BK000035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2916837-2021-00239 WAS SENT IN ERROR. THE COMPLAINT IS ON QC CONTROL LEUCOCOUNT RBD SAMPLES AND THEREFORE, IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD LEUCOCOUNT¿ LOW RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOW RESULTS OBTAINED WITH RBC HIGH COMPARED TO EXPECTED VALUES. NOTICED AFTER USE. RESULTS OBTAINED WITH RBCH CONTROLS WERE LOWER THAN EXPECTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G.5. PMA / 510(K)#: BK000036. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD LEUCOCOUNT¿ LOW RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOW RESULTS OBTAINED WITH RBC HIGH COMPARED TO EXPECTED VALUES. NOTICED AFTER USE. RESULTS OBTAINED WITH RBCH CONTROLS WERE LOWER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733235 BD LEUCOCOUNT COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 341003 LR0321H 00382903410033

    Patients

    Seq Age Sex Outcome Treatment
    1