BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1600 CS

    MDR report key: 107607 · Received July 22, 1997

    Report

    Report Number
    2919069-1997-00005
    Event Type
    Malfunction
    Date Received
    July 22, 1997
    Date of Event
    June 16, 1997
    Report Date
    July 21, 1997
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CODE 81: AN FSR WAS DISPATCHED TO THE CUSTOMER SITE. A RETURN WAS NOT RECEIVED FOR INVESTIGATION. INVESTIGATION SUMMARY: A REVIEW OF THE CLIENT'S CALL HISTORY INDICATED THAT THE CUSTOMER'S COMPLAINT WAS RESOLVED IN THE FIELD. A FIELD SERVICE REP. (FSR) VISITED THE SITE AND REPLACED THE SAMPLE AND DILUENT SYRINGE DRIVES. CONTROLS, BACKROUND AND PRECISION WERE RUN TO VERIFY PERFORMANCE. FURTHER REVIEW OF THE CLIENT'S CAL HISTORY INDICATED THAT THERE HAVE NOT BEEN ANY FURTHER ISSUES OF ERRATIC RESULTS. NO CORRECTIVE ACTION REQUIRED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 6/16/97, THE ACCOUNT REPORTS ERRATIC CBC RESULTS, WHICH WERE RUN ON THE CELL DYN 1600CS HEMATOLOGY ANALYZER. THE SAMPLE WAS DRAWN IN A 5 ML EDTA TUBE AT 1828 PM. RESULTS REPORTED WERE: WBC=16.3; RBC=3.46; HGB=10.4; HCT=30.4; MCV=88; PLT=339. THE PT'S PHYSICIAN QUESTIONED THE RESULTS AND SENT THE PT TO A HOSP TO BE REDRAWN. THE PT WAS REDRAWN AT 2310 PM. RESULTS RECEIVED WERE: WBC=22.2; RBC=2.01; HGB=6.2; HCT=17.9; MCV=89; PLT=493. THE PT WAS TRANFUSED BASED ON THE HOSP RESULTS. THE ACCOUNT DID NOT REPEAT THE ORIGINAL SAMPLE FOR CONFIRMATION OF RESULTS. NO FURTHER PT INFO RECEIVED FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1600 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR