BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 145097 · Received January 16, 1998

    Report

    Report Number
    2919069-1998-00001
    Event Type
    Other
    Date Received
    January 16, 1998
    Date of Event
    December 15, 1997
    Report Date
    January 16, 1998
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS LINKED WITH WITH ID #. A FILED SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE CUSTOMER SITE. COMPLAINT EVALUATION: THE CUSTOMER COMPLAINT COULD NOT BE REPRODUCED OR CONFIRMED AS THE UNIT WAS NOT EXPECTED TO BE RETURNED. THE FSR WHO INVESTIGATED THE COMPLAINT AT THE CUSTOMER SITE CHECKED THE SYSTEM OPERATION AND FOUND THE GAINS FOR WBC, RBC, AND PLT TO BE LOW ACCORDING TO SPECIFICATIONS IN THE CD1700 SERVICE MANUAL. AFTER THE GAINS WERE ADJUSTED, THE MCV WAS FOUND TO BE OUT OF RANGE, AND THE AUTOCAL WAS RUN. CONTROLS WERE CHECKED AND THE CUSTOMER VERIFIED INSTRUMENT OPERATION. THERE WAS NO REPORT IF THE SPECIMEN IN QUESTION WAS REPEATED AFTER ADJUSTMENT OF THE GAINS. NO FURTHER CORRECTIVE ACTION IS REQUIRED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 12/15/1997 THE ACCOUNT REPORTED A DISCREPANT PLATELET COUNT OF 120K/UL ON A PT WHO HAD BEEN RUNNING ABOUT 10K/UL. THE PHYSICIAN QUESTIONED THE RESULTS AND THE SAMPLE WAS RETESTED TWICE, GIVING RESULTS OF 2K/UL BOTH TIMES. NO FLAGS WERE GENERATED WITH THE FIRST DISCREPANT RESULT. AFTER CONFIRMATION OF THE LOW RESULTS, MORE PLATELET TRANSFUSIONS WERE GIVEN TO THE PT. ACCORDING TO THE ACCOUNT, ALL SLIDES ARE REVIEWED; HOWEVER, THE SLIDE FOR THIS PT WAS NOT REVIEWED PRIOR TO REPORTING THE DISCREPANT RESULT. THE ACCOUNT ALSO STATED THAT THE SAMPLE WAS MIXED PRIOR TO ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO