BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1961346 · Received January 14, 2011

    Report

    Report Number
    2919069-2011-00022
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CRACKED RBC AND WBC APERTURE PLATES. A FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE CRACKED RBC AND WBC APERTURE PLATES, PERFORMED VERIFICATION PROCESS, AND RAN PRECISION, WHICH PASSED. THE FSR VERIFIED PROPER INSTRUMENT OPERATION. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL PROVIDES INFORMATION TO ASSIST IN PROBLEM IDENTIFICATION, ISOLATION, AND CORRECTIVE ACTIONS. SECTION 9: SERVICE AND MAINTENANCE, SUBSECTION: PREVENTIVE MAINTENANCE SCHEDULE, INDICATES THAT REPLACEMENT OF THE APERTURE PLATES IS AN AS-REQUIRED PROCEDURE. THE CELL-DYN 1800 OPERATOR'S MANUAL ALSO INDICATES THAT IF THE APERTURE PLATES BECOME CRACKED OR DAMAGED, THEY MUST BE REPLACE AND INSTRUCTIONS ARE PROVIDED. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED FOR THE REPORTED ISSUE FROM (B)(4) 2010 THROUGH (B)(4) 2011. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY DEPRESSED CELL-DYN 1800 PLATELET COUNT OF 2 K/UL WITH NO PLATELET FLAGGING ON A SPECIMEN THAT REPEATED AT 65 K/UL. THE ACCOUNT STATED THE PLATELET BACKGROUND AND QUALITY CONTROL WAS WITHIN RANGE. THE FALSELY DEPRESSED PLATELET COUNT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS 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