BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1821045 · Received August 31, 2010

    Report

    Report Number
    2919069-2010-00427
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. OTHER TEXT : AN INVESTIGATION IS IN PROCESS

    Description of Event or Problem · 1

    THE CUSTOMER STATED ERRATIC HEMOGLOBIN RESULTS WERE GENERATED ON THE CELL-DYN 1800 ANLAYZER. ONE PATIENT SAMPLE, FROM A PREVIOUS CANCER PATIENT, GENERATED HEMOGLOBIN RESULTS OF 7.3, 12.0 AND 10.2 G/DL. ADDITIONALLY, THERE WERE INTERMITTENT HEMOGLOBIN RESULTS OF 0.0 G/DL GENREATED ON THE CELL-DYN FOR BOTH PATIENT AND CONTROL SAMPLES. NO DISCREPANT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 HGB, FLOWCELL, (B)(4)| HGB, FLOWCELL, (B)(4)