BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 4000 VENT NEEDLE

    MDR report key: 1811570 · Received August 23, 2010

    Report

    Report Number
    2919069-2010-00420
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    D007075
    Removal / Correction Number
    2919069-7/26/10-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE: CELL-DYN 4000 HEMATOLOGY ANALYZER, LIST # 1H03-01, (B)(4). THE CAUSE OF THE CELL-DYN 4000 VENT NEEDLE 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 4000 VENT NEEDLES AND REPLACE WITH A NEW CELL-DYN VENT NEEDLE PROVIDED TO THE CUSTOMER WITH THE RECALL LETTER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED THE CELL-DYN 4000 VENT NEEDLE LIFTING UP THE SPECIMEN TUBE WHEN THE ANALYZER WAS OPERATING IN A CLOSED MODE. THE VENT NEEDLE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 VENT NEEDLE VENT NEEDLE USED ON THE CD 4000 GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 CELL-DYN 4000 ANALYZER, LIST # 1H03-01