BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1700 CS

    MDR report key: 516274 · Received January 20, 2004

    Report

    Report Number
    2919069-2004-00003
    Event Type
    Other
    Date Received
    January 20, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 19, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1700 ANALYZER GENERATED ERRATIC PT HEMOGLOBIN RESULTS OF 6.8, 9.8, AND 11.5 G/DL FROM THE SAME COLLECTION TUBE. RESULTS WERE NOT REPORTED FROM THE SAME COLLECTION TUBE. RESULTS WERE NOT REPORTED FROM THE LAB. THE CUSTOMER STATES THAT ALL CONTROLS WERE WITHIN SPECIFICATION AT THE BEGINNING OF THE SHIFT AND A PRECISION STUDY PERFORMED THE DAY BEFORE MET ALL SPECIFICATIONS. THE CUSTOMER DID MENTION THAT THE SAMPLE WAS ASPIRATED NEAR THE BOTTOM OF THE COLLECTION TUBE AND THE SPECIMEN WAS FREE OF CLOTS. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) ADVISED THE CUSTOMER TO REPEAT THE CONTROLS AT THE END OF THE DAY. THE CUSTOMER DID SO AND REPORTED THAT THE LOW AND HIGH LEVEL CONTROLS CAME INTO SPECIFICATION ON THE FIRST ASPIRATION BUT THAT THE NORMAL CONTROLS HAD TO BE REPEATED TWICE BEFORE ALL PARAMETERS CAME WITHIN SPECIFICATIONS. THE NEXT DAY, THE CUSTOMER RAN CONTROLS AT THE BEGINNING OF THE SHIFT AND THIS TIME THE LOW CONTROL HAD TO BE REPEATED ONCE BEFORE ALL PARAMETERS CAME INTO SPECIFICATIONS. THE NORMAL AND HIGH CONTROLS WERE WITHIN SPECIFICATIONS ON THE INITIAL ASPIRATIONS. THE PT RETURNED FOR A REDRAW. THE SAMPLE GENERATED A HEMOGLOBIN RESULT OF 12.5 G/DL, WHICH WAS REPORTED FROM THE LAB. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1700 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR