BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 2191962 · Received August 4, 2011

    Report

    Report Number
    2919069-2011-00532
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4): NO PATIENT INVOLVEMENT. (B)(4): POWER SOURCE ISSUE. AN EXPANDED INVESTIGATION THROUGH CORRECTION AND REMOVAL (B)(4) 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 INFORMATION LETTER DATED (B)(4) 2010, (RE-ENFORCING THE PRODUCT CORRECTION LETTER PREVIOUSLY SENT ON (B)(4) 2009) 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 3700 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).

    Description of Event or Problem · 1

    THE CUSTOMER HAD THE CELL-DYN ANALYZER INSPECTED AND THE POWER SUPPLY FUSE WAS REPLACED WITH THE CORRECT PART SINCE THE ONE WAS INSTALLED DID NOT MATCH THE CORRECT VOLTAGE IN THE CUSTOMER'S LAB. 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 3700 SL ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 POWER SUPPLY FUSE