BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 1023655 · Received April 1, 2008

    Report

    Report Number
    2919069-2008-00478
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: SPECIMEN MISIDENTIFICATION. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATES THAT WHEN PROCESSING A PATIENT SAMPLE USING THE CELL-DYN SAPPHIRE ANALYZER THAT AN ERROR AFFECTING SAMPLE IDENTIFICATION OCCURRED. THE CUSTOMER USES A HAND-HELD BARCODE READER. A BARCODED SPECIMEN THAT SHOULD HAVE READ 974663 WAS INCORRECTLY READ AS 944663. THE TECHNICIAN NOTICED THE ERROR IMMEDIATELY AND NO INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LAB WITH NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CDS/4K HAND-HELD BARCODE READER LIST NO 7H40-01| SERIAL NO UNKNOWN