BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHOLE BLOOD QUALITY CONTROL

    MDR report key: 1625802 · Received February 23, 2010

    Report

    Report Number
    2250033-2010-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 24, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD AND RESULTS: MANUFACTURER UNABLE TO PERFORM EVALUATION AS QUALITY CONTROL PRODUCT NOT BEING RETURNED FROM USER FACILITY. DEVICE HISTORY RECORD REVIEWED. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A NURSE ACCIDENTLY PRICKED HER FINGER WITH THE END OF THE SYRINGE CONTAINING THE CONTROL. CUSTOMER STATED NURSE IS FINE AND HEALTHY. 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 CORPORATION QCACT L9WQC023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other