BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1479556 · Received September 22, 2009

    Report

    Report Number
    2919069-2009-00335
    Event Type
    Malfunction
    Date Received
    September 22, 2009
    Date of Event
    September 21, 2009
    Report Date
    September 21, 2009
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IN PROCESS, NO METHOD, RESULTS OR CONCLUSION CODE CAN BE CHOSEN AT THIS TIME. 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). EVALUATION RESULTS: SPM PRINTED CIRCUIT BOARD ASSEMBLY. IN RESPONSE TO THIS ISSUE AN INVESTIGATION WAS INITIATED TO FURTHER INVESTIGATE THE CUSTOMER ISSUE. THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SERVICE VISIT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE FIELD SERVICE REPRESENTATIVE (FSR) FOUND THE SIGNAL PROCESSOR MODULE (SPM) FOR THE RBC EDIT RATIO (RER) AND PLT OUT OF SPECIFICATION. THE FSR REPLACED THE SPM PRINTED CIRCUIT BOARD ASSEMBLY AND PERFORMED GAIN ADJUSTMENT FOR RER AND PLT. THE INSTRUMENT WAS THEN PERFORMING WITHIN SPECIFICATIONS. TRACKING AND TRENDING DID NOT INDICATE ANY ADVERSE COMPLAINT TREND EXISTS FOR DISCREPANT PLATELET RESULTS ON THE CELL-DYN 1800. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO DISCREPANT PLATELET RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN 1800 ANALYZER GENERATED FALSELY ELEVATED PLATELET RESULTS. THE CUSTOMER STATED THE ANALYZER GENERATED PLATELET RESULTS OF ONE MILLION WHILE THE PATIENT'S CORRECT RESULT WAS 200 K/UL. THE CUSTOMER STATED THE ANALYZER DID NOT GENERATE ANY ERRORS OR FLAGS, AND QUALITY CONTROLS WERE IN RANGE. THE INCORRECT PATIENT RESULTS WERE NOT REPORTED, AND NO TREATMENT WAS GIVEN TO THE PATIENT. THE CUSTOMER DECLINED TO PROVIDE INSTRUMENT DATA, SPECIFIC PATIENT DATA, OR INFORMATION ON HOW THE CORRECT PLATELET VALUE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN 1800

    Patients

    Seq Age Sex Outcome Treatment
    1