BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1962126 · Received January 17, 2011

    Report

    Report Number
    2919069-2011-00025
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Report Date
    December 29, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Removal / Correction Number
    2919069-4/7/10-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ASPIRATION BOTTOM SENSOR WORN-OUT FROM NORMAL USE. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. NO PRODUCT DEFICIENCY WAS IDENTIFIED AND THE ISSUE WAS RELATED TO A WORN-OUT PART DUE TO NORMAL USE. A MANDATORY TECHNICAL SERVICE BULLETIN (TSB) IS ISSUED WITH INSTRUCTIONS FOR FIELD SERVICE TO INSPECT AND REPLACE THE PART WHEN NECESSARY. THE PREVENTIVE MAINTENANCE PROCEDURES WILL BE UPDATED IN THE OPERATORS MANUAL TO INCLUDE INSPECTION OF THE ASPIRATION PROBE SENSOR EVERY SIX MONTHS AND REQUEST REPLACEMENT IF REQUIRED. A DESIGN IMPROVEMENT IS IN PROCESS TO IMPROVE THE CABLE AND SEAL THE BOARD AND SWITCH ASSEMBLIES. A CORRECTION THROUGH A FOLLOW-UP CORRECTION AND REMOVAL FA01OCT2010 WAS ISSUED TO INCLUDE INSTALLING A NEW SOFTWARE (V4). THE NEW V4 SOFTWARE RELEASED WITH FA01OCT2010 INCLUDES A DESIGN IMPROVEMENT FOR THE ASPIRATION BOTTOM SENSOR. (B)(4).

    Description of Event or Problem · 1

    WHILE INSTALLING THE NEW CELL-DYN SAPPHIRE SOFTWARE VERSION 4, A DEFECTIVE ASPIRATION BOTTOM SENSOR WAS DETECTED. THE PROBE WAS NOT IN THE HOME POSITION AND THE ASPIRATION BOTTOM SENSOR WAS REPLACED AT THE CUSTOMER'S SITE IN ORDER TO RESOLVE THIS 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 SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 ASPIRATION BOTTOM SENSOR