BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3000 CS ANALYZER

    MDR report key: 2061115 · Received April 18, 2011

    Report

    Report Number
    2919069-2011-00166
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 18, 2011
    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
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), MODEL NUMBER-91325-1 AND 91325-03-CELL-DYN 3000 SL ANALYZER. A PRODUCT CORRECTION LETTER AND ADDITIONAL LABEL, PN 9231344, WILL BE SENT TO ALL ACTIVE CELL-DYN 3000 CUSTOMERS REQUESTING THAT THEY AFFIX THE FUSE LABEL TO THE REAR INSTRUMENT PANEL. CUSTOMERS WILL BE ALSO ASKED TO CHECK THE FUSE THAT IS CURRENTLY INSTALLED ON THEIR INSTRUMENT. UPDATED SECTIONS OF THE OPERATORS MANUAL WERE ALSO SENT TO THE CELL-DYN 3000 CUSTOMERS. IF THE CUSTOMER DOES NOT HAVE THE CORRECT AMPERE RATING MATCHES THE VOLTAGE OF OPERATION, THE CUSTOMER IS INSTRUCTED ON REPLACING THE FUSE WITH THE CORRECT ONE PROVIDED IN THE ACCESSORY KIT SHIPPED WITH THE CELL-DYN ANALYZER. IF THE CORRECT FUSE IS NOT AVAILABLE, THE CUSTOMER IS INSTRUCTED TO CONTACT THE LOCAL FIELD SERVICE REPRESENTATIVE IN ORDER TO BE PROVIDED WITH THE CORRECT FUSE. THE CELL-DYN 3000 ANALYZER WAS RETIRED AS OF (B)(4) 2010, THEREFORE, NO NEW CUSTOMERS ARE TO BE IMPACTED.

    Description of Event or Problem · 1

    THE CELL-DYN 3000 SYSTEM IS A MULTIPARAMETER HEMATOLOGY ANALYZER DESIGNED FOR IN-VITRO DIAGNOSTIC USE IN CLINICAL LABORATORIES AS WELL AS PHYSICIAN OFFICE LABS. THE ANALYZER HAS A FUSE (B)(4). PER EXISTING LABELING, THE FUSE SHOULD BE USED AS FOLLOWS: FOR 100/120 VOLTS, ONLY AN 8-AMP T (SLOW BLOW) FUSE. FOR 220/240 VOLTS, ONLY A 4-AMP T (SLOW BLOW) FUSE. OCCURRENCES WERE REPORTED WHERE THE INCORRECT POWER SUPPLY FUSE FOR THE OPERATIONAL VOLTAGE WAS INSTALLED IN SIMILAR CELL-DYN ANALYZERS. IN THE FAILURE MODE, THE INSTRUMENT WILL BE RENDERED INOPERABLE PENDING A FIELD SERVICE CALL WHICH COULD CAUSE A DELAY OF GENERATING PATIENT RESULTS. THE INCIDENTS OF POTENTIAL SMOKE AND / OR FIRE COULD AFFECT USER SAFETY. NO INCIDENTS OF SMOKE OR FIRE OR ANY IMPACT TO USER SAFETY WERE REPORTED FOR THIS CELL-DYN ANALYZER. A PRODUCT CORRECTION LETTER HAS BEEN ISSUED AND REPORTED UNDER 21CFR806 FOR THE CEL-DYN 3000 SYSTEM TO THE FDA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3000 CS ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 POWER SUPPLY FUSE