BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1883430 · Received October 26, 2010

    Report

    Report Number
    2919069-2010-00508
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 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
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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. WITH V4, THE CD SAPPHIRE WILL EXECUTE SENSOR CHECKS TO DETERMINE THE STATUS OF THE SENSOR AND WILL GENERATE AN ERROR MESSAGE IF AN ISSUE IS DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S CELL-DYN BOTTOM SENSOR CABLE WAS CRACKED AND THE BOTTOM SENSOR WAS REPLACED PER FA05APR2010 IN ORDER TO RESOLVE THE 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 BOTTOM SENSOR CABLE