BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-SED ABNORMAL ESR CONTROL

    MDR report key: 1633049 · Received March 15, 2010

    Report

    Report Number
    2016706-2010-00001
    Event Type
    Other
    Date Received
    March 15, 2010
    Date of Event
    February 18, 2010
    Report Date
    March 15, 2010
    Manufacturer
    VITAL DIAGNOSTICS, INC.
    Product Code
    JJY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING AND CERTIFICATE OF ANALYSIS OF THE CONTROL MATERIAL INDICATE THAT EACH HUMAN DONOR UNIT USED TO MANUFACTURE THIS CONTROL WAS TESTED BY FDA-ACCEPTED METHODS AND FOUND NON-REACTIVE FOR (B)(6) IN ADDITION, THE LABELING INSTRUCTS THE USERS TO TREAT ALL HUMAN SOURCE MATERIAL AS POTENTIALLY INFECTIOUS AND SHOULD BE HANDLED WITH THE SAME PRECAUTIONS USED WITH PT SPECIMENS. ROOT CAUSE OF EVENT: USER ERROR.

    Description of Event or Problem · 1

    THE MEDICAL TECHNOLOGIST'S INDEX FINGER WAS CUT UNDER THE FINGERNAIL WHILE REMOVING A VIAL OF VITAL DIAGNOSTICS ACCU-SED ABNORMAL ESR CONTROL FROM THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-SED ABNORMAL ESR CONTROL QUALITY CONTROL MATERIAL JJY VITAL DIAGNOSTICS, INC. NA 9278110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other