BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780

    MDR report key: 1190655 · Received October 6, 2008

    Report

    Report Number
    1061932-2008-00051
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN RANGE BEFORE AND AFTER THE EVENT. SAMPLE INFORMATION WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE COSTUMER'S LAB: THE FSE REPLACED THE WHITE BLOOD CELL (WBC) BATH FOR BETTER DRAINAGE. ALTHOUGH HARDWARE ISSUE WAS ADDRESSED BY THE FSE, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, REGARDING ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULTS GENERATED BY THE COULTER LH 780 ANALYZER FOR TWO PT SAMPLES. INITIAL HGB RESULTS WERE: 10.4G/DL AND 11.7G/DL FOR PT A AND B RESPECTIVELY. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLES WERE RE-TESTED AND HIGHER RESULTS WERE OBTAINED: HGB RESULT WAS 11.3G/DL FOR PT A, AND 12.9G/DL FOR PT B. CORRECTED REPORTS WERE SENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO DEATH, INJURY OR CHANGE TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA