BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY

    MDR report key: 1811565 · Received August 23, 2010

    Report

    Report Number
    2919069-2010-00419
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    D019916
    Removal / Correction Number
    2919069-7/26/10-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: CELL-DYN SAPPHIRE HEMATOLOGY ANALYZER, LIST # 8H00-01, (B)(4). THE CAUSE OF THE CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY ASPIRATION ERROR (UNDETECTED SHORT SAMPLE) WAS DUE TO A DEFECTIVE CELL-DYN VENT NEEDLE FROM THE SUPPLIER. A PRODUCT RECALL INFORMED ABBOTT CUSTOMERS TO DISCARD ANY CELL-DYN SAPPHIRE VENT HEAD ASSEMBLIES AND REPLACE WITH A NEW CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY PROVIDED TO THE CUSTOMER WITH THE RECALL LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE CELL-DYN SAPPHIRE ANALYZER NEEDLE WAS NOT IN THE STARTING POSITION. THE CUSTOMER WAS ADVISED TO REPLACE THE CELL-DYN SAPPHIRE VENT NEEDLE AND THE CUSTOMER PERFORMED A TEST RUN AND THE ERROR WAS NOT GENERATED. THE CUSTOMER OBSERVED QUALITY CONTROLS AND PATIENT RESULTS RUNNING AT APPROPRIATE VALUES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY VENT NEEDLE USED ON THE CELL-DYN ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 CELL-DYN SAPPHIRE ANALYZER, LIST # 8H00-01