BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3200 SL 110V ANALYZER

    MDR report key: 1894328 · Received November 9, 2010

    Report

    Report Number
    2919069-2010-00526
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Removal / Correction Number
    2919069-3/31/09-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EXPANDED INVESTIGATION THROUGH CORRECTION AND REMOVAL FA25AUG2010 WAS CONDUCTED TO EVALUATE THIS ISSUE. THE ROOT CAUSE IDENTIFIED FOR THIS ISSUE IS INSTALLATION OF THE INCORRECT FUSE BY EITHER THE CUSTOMER OR THE FIELD SERVICE REPRESENTATIVE. FUSES ARE NOW REMOVED PRIOR TO SHIPPING THE ANALYZER. LABELING ON THE BAG THAT INCLUDED 220/240 VOLTAGE DESIGNATION ON THE 8 AMPERAGE FUSE WAS REMOVED. FIELD SERVICE REPRESENTATIVE ARE ALSO REQUIRED TO CHECK THE FUSE DURING INSTALLATION AND MAINTENANCE. A PRODUCT INFORMATION LETTER DATED (B)(6) 2010 ALONG WITH A LABEL AFFIXED TO THE BACK OF THE INSTRUMENT INSTRUCTING THE CUSTOMER TO CHECK IF THE FUSE MATCHES THE VOLTAGE OF OPERATION THAT IS CURRENTLY BEING UTILIZED WITH THE CUSTOMERS CELL-DYN 3200 ANALYZER. SINCE THE FUSE IS A CUSTOMER REPLACEABLE PART, INSTRUCTIONS WERE ALSO PROVIDED TO THE CUSTOMER TO REFER TO THE TROUBLE SHOOTING SECTION IN THE OPERATORS MANUAL FOR REPLACING AN INCORRECT FUSE (REPLACEMENT FUSES WERE PROVIDED IN THE ACCESSORY KIT SHIPPED WITH THE CELL-DYN SYSTEM). IN THE EVENT THAT THE CORRECT FUSE IS NOT INCLUDED IN THE ACCESSORY KIT, THE CUSTOMERS ARE INSTRUCTED TO CONTACT THEIR LOCAL CUSTOMER SUPPORT REPRESENTATIVE IN ORDER FOR A REPLACEMENT FUSE TO BE PROVIDED TO THE CUSTOMERS.

    Description of Event or Problem · 1

    AFTER RECEIVING THE FA25AUG2010 LETTER, THE CUSTOMER REPORTED AN INCORRECT POWER SUPPLY FUSE INSTALLED IN THE CELL-DYN ANALYZER. THE CORRECT 4-AMPERE FUSE WILL BE SHIPPED TO THE CUSTOMER. THE CUSTOMER ALSO REPORTED ERROR CODE OF 17 OCCURRED WHEN THE LOADER NEEDLE STARTS TO DESCEND. THE ISSUE WAS RESOLVED BY REPLACING THE POWER SUPPLY FAN AND THE WHITE BLOOD CELL (WBC) FLOW CELL DUE TO LEAKS. NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    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 POWER SUPPLY FUSE