BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 1002792 · Received February 26, 2008

    Report

    Report Number
    2919069-2008-00400
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    November 8, 2007
    Report Date
    February 6, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-8/6/07-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED ABBOTT REGARDING HEMOGLOBIN SYRINGE "FAIL TO HOME" ERROR MESSAGES GENERATED FROM THE CELL-DYN SAPPHIRE HEMATOLOGY ANALYZER. THE CUSTOMER REPORTED SYRINGES HAVE BEEN REPLACED IN 2007, AND TWO TIMES IN 2008 FOR SYRINGE "FAIL TO HOME" ERROR MESSAGES. THE CUSTOMER REQUESTS REPLACEMENT SYRINGES AS THERE WERE NO OTHER REPLACEMENTS AVAILABLE. THE CUSTOMER RECEIVED THE REPLACEMENT SYRINGES, INSTALLED A REPLACEMENT ON THE ANALYZER AND THE ISSUE WAS RESOLVED. THE CUSTOMER REPORTED ALL QUALITY CONTROLS WERE WITHIN RANGE AND THE INSTRUMENT PERFORMANCE WAS WITHIN SPECS. ADDITIONALLY, THE CUSTOMER REPORTED THERE WAS NO IMPACT TO PT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE