BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHOLE BLOOD QUALITY CONTROL

    MDR report key: 1626500 · Received March 2, 2010

    Report

    Report Number
    2250033-2010-00004
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    January 27, 2010
    Report Date
    March 2, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER METHOD: MANUFACTURER UNABLE TO PERFORM EVALUATION AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM USER FACILITY. DEVICE HISTORY RECORD REVIEWED. RESULTS: MANUFACTURER UNABLE TO PERFORM EVALUATION AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM USER FACILITY. DEVICE HISTORY RECORD REVIEWED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS NURSE ACCIDENTLY PRICKED HER FINGER WITH THE SYRINGE USED TO EXTRACT THE RECONSTITUTED CONTROL FROM THE HEMOCHRON RESPONSE CONTROL VIAL. CUSTOMER STATED NURSE WILL BE MONITORED FOR ADVERSE REACTIONS TO THE BLOOD EXPOSURE. NO REPORT OF SERIOUS INJURY, OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHOLE BLOOD QUALITY CONTROL WHOLE BLOOD QUALITY CONTROL ACT GGN INTERNATIONAL TECHNIDYNE CORP. QCACT M9WQC027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other