BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 1036182 · Received April 29, 2008

    Report

    Report Number
    2919069-2008-00493
    Event Type
    Malfunction
    Date Received
    April 29, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-4/15/08-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND AN ISSUE WITH THE CELL-DYN SAPPHIRE LABORATORY INFO SYSTEM (LIS) / MIDDLEWARE INTERFACE CHANGE SPECIFICATION, LIST #08H09-01. THESE CHANGES ARE OPTIONAL, THIS MEANS THAT, IF CUSTOMERS DO NOT WANT THE ADD'L FEATURES ACTIVATED, THEIR LIS WILL NOT CHANGE. THE LIS TRANSMISSION FOR VERSION R2-5 SOFTWARE CONTAINS A CHANGE IN THE ORDER OF RESULTS TRANSMITTED TO THE LIS, WHICH HAS CREATED THE ISSUE WITH SOME EXISTING LIS IF THE CUSTOMER DOES NOT CORRECTLY MAP THE LIS BY THE NUMERICAL RESULT LABEL PRIOR TO UPGRADING TO R2-5 SOFTWARE. BASED ON THE ABOVE INVESTIGATION, A PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE LIS / MIDDLEWARE INTERFACE SPECIFICATION, LIST #08H09-01. A REVIEW OF THE DOMESTIC AND INTERNATIONAL COMPLAINTS FOR THE MONTHS OF OCTOBER 2007 THROUGH JANUARY 2008 DID NOT FIND AN ADVERSE TREND ON THE LIST BASE HEM SOFTWARE FOR THIS ISSUE. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    DISCREPANCIES HAVE BEEN IDENTIFIED IN THE RESULTS RECORDS SECTION AND THE CELL-DYN SAPPHIRE NUMERICAL RESULT LABEL SECTION OF THE CELL-DYN SAPPHIRE LABORATORY INFO SYSTEM (LIS) / MIDDLEWARE INTERFACE CHANGE SPECIFICATIONS. CONFIGURATION OF RESULTS TRANSMISSION FROM THE CELL-DYN SAPPHIRE TO THE (LIS) WAS OBSERVED. ALL RESULTS EXCEPT THE WHITE BLOOD CELLS WERE INTERPRETED IN AN UNEXPECTED ORDER. FOR EXAMPLE, THE HEMOGLOBIN VALUE WOULD BE INTERPRETED AS THE RED BLOOD CELLS RESULT. THE TRANSMISSION OF THE MISINTERPRETED RESULTS OCCURS WITHOUT THE CUSTOMER BEING AWARE OF THE ISSUE. A RECALL WAS ISSUED AND REPORTED.

    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 LIS/MIDDLEWARE| INTERFACE SPECIFICATION LIST # 8H09-01