BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3200 SL 110V ANALYZER

    MDR report key: 1960995 · Received January 14, 2011

    Report

    Report Number
    2919069-2011-00021
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). BUBBLES IN FLOW SYSTEM. THE CUSTOMER TECHNICAL ADVOCATE (CTA) WAS ABLE TO DETERMINE THAT THE ISSUE WITH THE HIGH PLATELET COUNTS WAS RESOLVED BY DRAINING AND REFILLING THE REAGENT RESERVOIRS AND THE OPTICAL FLOW CELL. THE INSTRUMENT AND QUALITY CONTROLS WERE PERFORMING WITHIN SPECIFICATIONS. THE LIKELY CAUSE OF THE ISSUE WAS RELATED TO BUBBLES IN THE FLOW SYSTEM. THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE CELL-DYN 3200 SL ANALYZER GENERATED AN INITIAL PLATELET RESULT OF 1,205,000/UL. THE RESULT WAS QUESTIONED AS IT WAS HIGHER THAN HISTORIC RESULTS. THE SAMPLE WAS REPEATED ON THE SAPPHIRE ANALYZER AND A RESULT OF 242,000/UL WAS GENERATED. THE SUSPECT RESULT WAS NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 SL 110V ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1