BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 829019 · Received February 21, 2007

    Report

    Report Number
    2919069-2007-00022
    Event Type
    Malfunction
    Date Received
    February 21, 2007
    Date of Event
    January 31, 2007
    Report Date
    January 31, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELL DYN
    Product Code
    GKZ
    PMA / PMN Number
    k030513
    Removal / Correction Number
    2919069-11/8/06-004C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A LAB CONSULTANT HAD QUESTIONS REGARDING PRODUCT CORRECTION LETTER FA27OCT2006 DUE TO HEMOGLOBIN QC BIASED LOW, BUT WITHIN ACCEPTABLE RANGE WHEN USING A CELL-DYN 1800 ANALYZER. THE CUSTOMER TECHNICAL ADVOCATE (CTA) REVIEWED THE CONTENTS OF THE LETTER WITH THE LAB CONSULTANT. THE LAB CONSULTANT STATED THAT THE LAB TEMPERATURE WAS NOT RECORDED DURING THE LAST CALIBRATION OF THE ANALYZER. THE LAB CONSULTANT STATES THAT THE LAB TEMPERATURE WILL BE MONITORED AND WILL PERFORM A CALIBRATION. NO PT RESULTS WERE QUESTIONED BY MEDICAL PRACTIONERS. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIV/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA