BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 928297 · Received October 17, 2007

    Report

    Report Number
    2919069-2007-00188
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    September 24, 2007
    Report Date
    September 28, 2007
    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
    LA, 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 OBSERVED "FAILED TO HOME" ERROR MESSAGES FOR THE ABBOTT CELL-DYN SAPPHIRE ANALYZER. THE CUSTOMER STATED THE "FAILED TO HOME" ERROR MESSAGES HAVE BEEN OCCURRING SPORADICALLY, AT LEAST 10 TIMES TOTAL IN ONE DAY. THE CUSTOMER'S REVIEW OF THE INSTRUMENT MAINTENANCE LOG INDICATED THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE WAS REMOVED AND REPLACED TWICE IN THE TWO WEEKS PRIOR TO THE OBSERVATION OF THE ERROR MESSAGE. THE CUSTOMER CONTACTED THE ABBOTT CUSTOMER SUPPORT CENTER AND WAS INSTRUCTED TO CLEAN THE HEMOGLOBIN SYRINGE. DURING THE CLEANING PROCEDURE, THE CUSTOMER OBSERVED THE SYRINGE DID NOT MOVE FREELY AND THE SYRINGE PLUNGER WAS VERY DIFFICULT TO MOVE. THE CUSTOMER DISCARDED THE PROBLEM SYRINGE AS INSTRUCTED IN ABBOTT'S CUSTOMER RECALL LETTER FOR THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE. THE CUSTOMER REPLACED THE SYRINGE AND THE ISSUE WAS RESOLVED. THE CUSTOMER STATED THAT NO PATIENT RESULTS WERE GENERATED OR REPORTED OUT OF THE LABORATORY.

    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 YR CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE| LIST # 08H49-02