BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1002795 · Received February 26, 2008

    Report

    Report Number
    2919069-2008-00397
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST # 08H49-02, PACKAGE DATE: (B)(4) 2007. UPON FURTHER REVIEW, THE ISSUE IS NO LONGER ASSOCIATED WITH REMEDIAL ACTION CORRECTION 2919069-8/6/07-004-C, AS THE CUSTOMER DID NOT HAVE THE SUSPECT CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE.

    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 THE SYRINGE GOT "TIGHT" IMMEDIATELY AFTER THE CUSTOMER STARTED TO USE IT AND THE ERROR MESSAGE OCCURRED. THE FAULTY SYRINGE WAS COLLECTED BY ABBOTT FIELD SERVICE ENGINEER AND ABBOTT CUSTOMER SUPPORT CENTER SENT A REPLACEMENT TO THE CUSTOMER. 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/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE,| CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE| LIST #08H49-02, PACKAGE DATE: