BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1000760 · Received February 21, 2008

    Report

    Report Number
    2919069-2008-00392
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 25, 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
    KY, 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 COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW UP MDR FOR REMEDIAL CORRECTION 2919069-8/6/07-004-C IS SUBMITTED LATE. CONCOMITANT MEDICAL PRODUCTS: CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE. LIST # 8H49-02. THIS FOLLOW UP MDR FOR REMEDIAL CORRECTION 2919069-8/6/07-004-C IS SUBMITTED LATE. UPON FURTHER REVIEW, THE CUSTOMER COMPLAINT IS ASSOCIATED WITH REMEDIAL CORRECTION 2919069-8/6/07-004-C, AS AN UNKNOWN LOT OF SUSPECT DEVICE WAS IN USE AT THE CUSTOMER FACILITY. THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST NUMBER 8H49-02, WAS MANUFACTURED ON (B)(4) 2007 AND WAS IDENTIFIED BY THE VENDOR TO HAVE BEEN MANUFACTURED WITH INSUFFICIENT OR INCONSISTENT AMOUNT OF SILICONE LUBRICANT APPLIED TO THE TIP OF THE SYRINGE PLUNGER. THE AFFECTED SYRINGES WITH A PACKAGE DATE OF (B)(4) 2007 THROUGH (B)(4) 2007, CAUSED THE CELL-DYN SAPPHIRE ANALYZER TO GENERATE AN ERROR MESSAGE UPON INSTALLATION OF THE SYRINGE OR SHORTLY THEREAFTER. THE CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE WAS DISTRIBUTED FOR THE CELL-DYN SAPPHIRE ANALYZER ONLY AND DID NOT IMPACT OTHER CELL-DYN ANALYZERS. THE ISSUE WAS RESOLVED WHEN A NEW CELL-DYN SAPPHIRE HEMOGLOBIN SYRINGE, LIST 8H49-04, WAS MANUFACTURED BY A NEW VENDOR AND RELEASED FOR DISTRIBUTION ON (B)(4) 2009.

    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 WAS ADVISED TO CLEAN THE SYRINGE AND/OR REPLACE IF NECESSARY. THE CUSTOMER REPORTED, THE ISSUE WAS RESOLVED BY REPLACING THE SYRINGE. 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/CELLDYN NA NA

    Patients

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