BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1242683 · Received November 26, 2008

    Report

    Report Number
    2919069-2008-00794
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 17, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OTHER: (B)(4) - DEVICE NOT RETURNED, INSUFFICIENT INFORMATION PROVIDED; (B)(4) - INCONCLUSIVE, NO DEVICE EVALUATION PERFORMED. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER EXAMINE THE CUSTOMER ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ON (B)(6) 2008, (B)(6), REPORTED DISCREPANT RESULTS ON TWO PATIENT SAMPLES GENERATED BY THE CELL-DYN SAPPHIRE, (B)(4). ABBOTT (B)(4) COMPLAINT INVESTIGATION DEPARTMENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO IDENTIFY THE CAUSE OF THE EVENT; HOWEVER, A REVIEW OF THE INSTRUMENT'S SERVICE TICKETS FROM (B)(6) 2008 THROUGH (B)(6) 2009, DID NOT SHOW ANY OTHER COMPLAINTS RELATED TO DISCREPANT RESULTS ON PATIENT SAMPLES. A REVIEW OF THE COMPLAINT TRENDING SYSTEM REPORTS, FOR THE PERIOD (B)(6) 2007 THROUGH (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN SAPPHIRE, L/N 08H00-01, DISCREPANT RESULTS ON PATIENT SAMPLES. THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL, LIST NUMBER 08H10-01, REVISION D, UNDER SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, PAGE 10-121, PROVIDES INFORMATION IN REGARDS TO TROUBLESHOOTING DATA-RELATED PROBLEMS. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE FOR DISCREPANT RESULTS ON PATIENT SAMPLES. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT LOW RESULTS WERE RECOVERED FROM TWO PATIENT SAMPLES WHEN ANALYZED ON THE CELL-DYN SAPPHIRE ANALYZER. THE RESULTS WERE ACCEPTABLE WHEN THE PATIENT SAMPLES WERE REPEATED ON ANOTHER CELL-DYN SAPPHIRE ANALYZER. SEE DATA BELOW.PATIENT 2 CELL- DYN SAPPHIRE CELL- DYN SAPPHIRE WBC (K/UL) 3.94 7.49RBC (M/UL) 3.39 4.05HGB (G/DL) 8.33 11.0HCT (%) 26.3 31.2PLATELET (K/UL) 276 326THE CUSTOMER STATES THAT THE SUSPECT LOW PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1