BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD1800 ANALYZER

    MDR report key: 856613 · Received May 25, 2007

    Report

    Report Number
    2919069-2007-00070
    Event Type
    Other
    Date Received
    May 25, 2007
    Date of Event
    April 26, 2007
    Report Date
    April 27, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED ALL REAGENT TUBING WAS WITHOUT OBSTRUCTION AND AIR BUBBLES, LYSE CAP INTACT, REAGENTS WERE CORRECT, AND ALL MAINTENANCE WAS UP TO DATE. ALL QC WAS WITHIN RANGE AND THE BUBBLE MIX IN THE PRE-MIX CUP AND BOTH TRANSDUCERS WAS VERIFIED. TEMPERATURE IN THE LABORATORY WAS CONSISTENT AT ALL TIMES. THE LAST CALIBRATION WAS PERFORMED IN 2007. THE DILUENT AND LYSE SYRINGES WERE WITHOUT POCKETS OR LEAKAGE; HOWEVER, THE 1 ML SAMPLE SYRINGE WAS LEAKING. THE CUSTOMER TECHNICAL ADVOCATE (CTA) RECOMMENDED REPLACING OR CLEANING THE SAMPLE SYRINGE, BUT THE CUSTOMER DECLINED TO PERFORM THE RECOMMENDED STEP. THE HGB REFERENCE = 1640 (TARGET IS 1800-2200). THE CTA INSTRUCTED THE CUSTOMER ON HOW TO PERFORM PRECISION. THE CTA DISPATCHED A FIELD SERVICE REPRESENTATIVE (FSR) TO FIX THE PROBLEM. THE FSR REPLACED THE LEAKING 1 ML SAMPLE SYRINGE AND TRAINED THE CUSTOMER ON HOW TO REPLACE THE PART. A REVIEW OF THE CELL DYN 1800 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 07H80-01, REV. D, SECTION 9, SERVICE AND MAINTENANCE, AS-REQUIRED MAINTENANCE, FOUND GUIDELINES ON HOW TO CLEAN AND REPLACE THE 1 ML SYRINGE. IN ADDITION, THE COMPLAINT ANALYSIS AND TRENDING SYSTEM WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL DYN 1800 ANALYZER GENERATED A HEMOGLOBIN (HGB) RESULT OF 7.5 G/DL. THE SAMPLE WAS REPEATED 2 TIMES WITH RESULT OF 11.1 G/DL AND 10.9 G/DL. THE CUSTOMER CHECKED THE PATIENT'S PREVIOUS HGB RESULT AND IT WAS 10.9 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR