BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 1002796 · Received February 26, 2008

    Report

    Report Number
    2919069-2008-00396
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 2, 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
    PA, 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 THREE DAYS POST INSTALLATION OF THE SYRINGE. THE CUSTOMER REPLACED THE SYRINGE WITH A NEW SYRINGE AND NO FURTHER ERRORS OCCURRED AND THE ISSUE WAS RESOLVED. 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| PACKAGE DATE: