BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 2823765 · Received September 1, 2010

    Report

    Report Number
    2823765
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    June 18, 2010
    Report Date
    August 31, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP
    Product Code
    JBP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WENT TO SURGERY FOR CEA WITH A BASELINE ACT OF 108. AT 11:08, PT WAS GIVEN 10,000 UNITS OF HEPARIN WITH AN ACT RESULT OF 150, AN ADD¿L 5,000 UNITS OF HEPARIN WERE GIVEN AT 11:18 WITH AN ACT RESULT OF 155, 5,000 MORE UNITS OF HEPARIN WERE GIVEN TO THE PT AT 11:26 AND ACT RESULTS WERE 190, AND FINALLY 5,000 MORE UNITS OF HEPARIN WERE GIVEN TO THE PT AT 11:38 AND THE ACT RESULT WAS 205. PT WAS TESTED SEVERAL MORE TIMES WITH THE HEMOCHRON SIGNATURE ELITE WITH THE HIGHEST RESULT BEING 238 AT 12:46. AFTER SEVERAL MORE HOURS THE ACT RESULT WAS 172 AT 13:25 AND A SPECIMEN WAS SENT TO THE MAIN LAB FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE ELITE ACT METER JBP INTERNATIONAL TECHNIDYNE CORP C0JAC079

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention