BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 1230983 · Received November 17, 2008

    Report

    Report Number
    2919069-2008-00782
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: NO DEVICE EVALUATION PERFORMED, CUSTOMER REFUSED SERVICE. INCONCLUSIVE, NO DEVICE EVALUATION PERFORMED. AN INVESTIGATION WAS CONDUCTED TO FIND OUT THE ROOT CAUSE OF THIS ISSUE. INFORMATION RECEIVED ON (B)(6) 2009 STATED THAT WHEN THE FIELD SERVICE ENGINEER CONTACTED THE CUSTOMER FOR REPAIR ESTIMATE, THE CUSTOMER CONFIRMED THAT THERE WAS NO PROBLEM WITH THE DATA AND DECIDED TO CONTINUE USING THE INSTRUMENT AND REFUSED THE SERVICE VISIT. THE CELL-DYN 3700 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 06H89-01, REVISION F, UNDER SECTION 10, TROUBLE SHOOTING GUIDE, PAGES 10-27 THROUGH 10-28, PROVIDES INSTRUCTIONS FOR PROBLEM IDENTIFICATION, PROBLEM ISOLATION AND CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) AND TRENDING ANALYSIS SUPPORT SYSTEM (TASS) FOR THE PERIOD OF (B)(6) 2007 THROUGH (B)(6) 2008, DID NOT INDICATE ANY ADVERSE TREND FOR THE CELL-DYN 3700, LIST NUMBER 2H31-01 FOR THE REPORTED ISSUE. (B)(6) 2008 THROUGH (B)(6) 2008 REPORTS HAVE BEEN EVALUATED AND NO POTENTIAL ADVERSE TRENDS HAVE BEEN IDENTIFIED. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR PLATELETS SCATTERED AND POOR REPRODUCIBILITY ON THE CELL-DYN 3700 INSTRUMENT. THERE WAS NO SYSTEMIC ISSUE FOR THE CELL-DYN 3700 PRODUCT LINE AS WELL. THIS IS A 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 ACCOUNT STATED THAT THE CELL-DYN 3700 SL ANALYZER GENERATED PLATELET RESULTS OF 8,370/UL, 20,100/UL AND 8,080/UL ON THE SAME PATIENT SAMPLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN

    Patients

    Seq Age Sex Outcome Treatment
    1