BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1700 ANALYZER

    MDR report key: 1883432 · Received October 26, 2010

    Report

    Report Number
    2919069-2010-00509
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 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
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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

    THE CUSTOMER INADVERTENTLY REPLACED THE CELL-DYN ANALYZER'S 5-AMPERE FUSE BY A 2.5-AMPERE FUSE PER FA27SEP2010 LETTER. THE 5-AMPERE FUSE HAD BEEN WORKING ON THE ANALYZER FOR YEARS WITHOUT AN ISSUE. THE ANALYZER TURNED OFF AFTER THE INSTALLATION OF THE 2.5-AMPERE FUSE AND THE FUSE WAS FOUND BLOWN-OUT. THE FA27SEP2010 LETTER WAS EXPLAINED TO THE CUSTOMER AND THE CORRECT 5-AMPERE FUSE WAS RE-INSTALLED TO RESOLVE THE ISSUE. 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 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 POWER SUPPLY FUSE