BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1896740 · Received November 10, 2010

    Report

    Report Number
    2919069-2010-00529
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: WBC FLAGGING GENERATED. THE DATA SUBMITTED BY THE CUSTOMER INDICATED THAT R1 FLAGS WERE GENERATED WITH THE LOW WBC COUNTS. THERE WAS NO INDICATION OF FURTHER MANUAL REVIEW OF THE SAMPLES. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL WAS REVIEWED AND WAS FOUND TO CONTAIN ADEQUATE TROUBLESHOOTING INSTRUCTIONS FOR DATA FLAGS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CD1800 ANALYZER GENERATED A LOW WBC RESULT OF 800/UL ON A PATIENT THAT HAD BEEN TESTED AT ANOTHER FACILITY WITH A RESULT OF AROUND 5,000/UL. THE SAMPLE WAS REPEATED WITH A RESULT OF 900/UL. THE PATIENT HAD ALSO BEEN TESTED ON (B)(6) 2010 WITH A WBC RESULT OF 3,400/UL. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    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