BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3500 CS ANALYZER

    MDR report key: 1839103 · Received September 20, 2010

    Report

    Report Number
    2919069-2010-00442
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    January 19, 2009
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K955715
    Removal / Correction Number
    2919069-3/31/09-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), CATALOG NUMBER: 91340-01, 91340-03 CELL-DYN 3500 CS ANALYZER. 91350-01, 91350-03 CELL-DYN 3500 SL ANALYZER. 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 3500 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

    ABBOTT CELL-DYN 3500 ANALYZER IS A MULTI-PARAMETER, AUTOMATED HEMATOLOGY ANALYZER DESIGNED FOR IN VITRO DIAGNOSTIC USE IN CLINICAL LABORATORIES. THE CELL-DYN 3500 ANALYZER HAS A FUSE LOCATED IN THE POWER SUPPLY UNIT ABOVE THE POWER CORD CONNECTOR ON THE REAR PANEL. THE FUSE IS AN ESSENTIAL PART OF THE POWER DISTRIBUTION SYSTEM AND PROTECTS THE ANALYZER AND COMPONENTS FROM DAMAGE. PER THE EXISTING LABELING, THE FUSE SHOULD BE REPLACED AS FOLLOWS: FOR 100/120 VOLTS: CUSTOMERS USE ONLY AN 8-AMP T (SLOW-BLOW) FUSE. FOR 220/240 VOLTS: CUSTOMERS USE ONLY A 4-AMP T (SLOW-BLOW) FUSE. CUSTOMERS HAVE REPORTED OCCURRENCES WHERE POWER SUPPLY UNITS HAVE BEEN RETURNED FOR INVESTIGATION WITH THE INCORRECT FUSE FOR THE OPERATIONAL VOLTAGE ON A SIMILAR CELL-DYN ANALYZER. UTILIZING A FUSE THAT DOES NOT MATCH THE VOLTAGE OF OPERATION MAY LEAD TO THE ANALYZER OR COMPONENT DAMAGE, SMOKE AND /OR FIRE. WHEN PRODUCTS ARE USED IN ACCORDANCE WITH THE CORRECT LABELING, THERE IS NO IMPACT TO PRODUCT FUNCTIONALITY OR PERFORMANCE, PATIENT RESULTS OR USER SAFETY. A PRODUCT CORRECTION LETTER HAS BEEN ISSUED AND REPORTED UNDER 21CFR806 FOR THE CELL-DYN ANALYZER TO THE FDA (B)(6) DISTRICT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3500 CS ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 FUSE