BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 1052462 · Received May 22, 2008

    Report

    Report Number
    2919069-2008-00550
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 11, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-4/15/08-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CUSTOMER STATED THAT AFTER INSTALLING THE NEW SOFTWARE OF THE CELL DYN SAPPHIRE ANALYZER, THEY HAVE BEEN EXPERIENCING PROBLEMS WITH THE HOST COMMUNICATION. SOME OF THE PT RESULTS WERE EITHER NOT TRANSFERRED OR NOT PRINTED THROUGH THE CELL DYN SAPPHIRE INTERFACE SPECIFICATION. THERE WAS NO IMPACT TO PT 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 CELL-DYN SAPPHIRE INTERFACE SPECIFICATION.| LIST # 8H09-01