BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 1842964 · Received September 23, 2010

    Report

    Report Number
    2919069-2010-00451
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    March 24, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Removal / Correction Number
    2919069-3/31/09-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. A PRODUCT INFORMATION LETTER DATED 20 APRIL 2010 (RE-ENFORCING THE PRODUCT CORRECTION LETTER PREVIOUSLY SENT ON 27 MARCH 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THIS ISSUE IS NOT ASSOCIATED WITH THE CORRECTION AND REMOVAL OF 2919069-3/31/09-002-C.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CELL-DYN ANALYZER GENERATED A MESSAGE (DISPENSING PROCESS RUNNING) WHILE THE CUSTOMER WAS PERFORMING THE DAILY MAINTENANCE. THE FIELD SERVICE ENGINEER INSPECTED THE INSTRUMENT AND REPLACED A DEFECTIVE FUSE WITH THE CORRECT ONE. NO IMPACT TO USER SAFETY OR PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 FUSE| FUSE