BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1700 CS ANALYZER

    MDR report key: 1953105 · Received January 7, 2011

    Report

    Report Number
    2919069-2011-00014
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Report Date
    December 16, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K870233
    Removal / Correction Number
    2919069-3/31/09-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EXPANDED INVESTIGATION THROUGH CORRECTION AND REMOVAL FA27SEP2010 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. A PRODUCT CORRECTION LETTER WAS SENT TO THE CUSTOMERS ALONG WITH THE FUSE LABEL TO BE AFFIXED TO THE BACK OF THE INSTRUMENT INSTRUCTING THE CUSTOMER TO CHECK IF THE FUSE MATCHES THE VOLTAGE OF OPERATION AND TO INSTALL THE CORRECT FUSE (PROVIDED IN THE ACCESSORY KIT SHIPPED WITH THE ANALYZER) FOLLOWING REPLACEMENT INSTRUCTIONS PROVIDED IN THE LETTER. THE CUSTOMERS ARE ALSO INSTRUCTED TO ORDER THE CORRECT FUSE IF IT IS NOT PROVIDED IN THE ACCESSORY KIT.

    Description of Event or Problem · 1

    AFTER REVIEWING THE INFORMATION LETTER OF FA27SEP2010, THE CUSTOMER REPORTED AN INCORRECT POWER SUPPLY FUSE (5 AMPERE) INSTALLED IN THE CELL-DYN ANALYZER. THE CORRECT FUSE (2.5 AMPERE) WAS SENT TO THE CUSTOMER. 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 1700 CS ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 POWER SUPPLY FUSE