BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 2874013 · Received December 14, 2012

    Report

    Report Number
    2919069-2012-00082
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, EVALUATION OF THE INSTRUMENT BY THE ABBOTT FIELD SERVICE ENGINEER (FSE), A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE FSE RESOLVED THE ISSUE BY REPLACING THREE (3) SOLENOID VALVES AND THE HGB LINE TUBING. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY OF THE CELL-DYN 3700SL ANALYZER, LIST NUMBER 02H31, WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED WBC COUNTS FOR ONE PATIENT WHILE USING THE CELL-DYN 3700SL ANALYZER. THE CUSTOMER INDICATED AN INITIAL RESULT OF 1520 (UNIT OF MEASURE NOT PROVIDED) AND A RETEST RESULT OF 370, WHICH WAS DEEMED CORRECT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED DUE TO THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3700 SL ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1