BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCO

    MDR report key: 1312410 · Received February 10, 2009

    Report

    Report Number
    2248721-2009-00045
    Event Type
    Other
    Date Received
    February 10, 2009
    Date of Event
    July 13, 2007
    Report Date
    February 10, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP (ITC)
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO RECENT RECEIPT OF INFO BY ITC CLARIFYING REPORTING RULES WHERE BOTH MULTIPLE PTS AND MULTIPLE DEVICES ARE INVOLVED. IN ACCORDANCE WITH THAT INFO, THIS F/U REPORT CLARIFIES THE PT - ADVERSE EVENT RELATIONSHIP AS OPPOSED TO PRIOR REPORTS WHICH NOTED THE DEVICE - ADVERSE EVENT RELATIONSHIP. CUSTOMER PROVIDED INVESTIGATION INFO. - EQC ACCEPTABLE, - LQC ACCEPTABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INCONSISTENT ACT RESULTS USING HEMOCHRON SIGNATURE ELITE / ACT-LR ON TWO PTS UNDERGOING UNSPECIFIED CATHETERIZATION PROCEDURE. THIS REPORT IS FOR PT 2 OF 2. AS INITIAL ACT OF 350 WAS SUBSEQUENTLY REPEATED WITH A 400 ACT RESULT. PHYSICIAN PERFORMED ADDITIONAL ACT USING ANOTHER SPECIMEN AND 2ND UNSPECIFIED HEMOCHRON SIGNATURE ELITE AND USED THAT ACT RESULT. NO ADVERSE EVENT, SERIOUS INJURY REPORTED FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCO HEMOCHRON SIGNATURE ELITE/ACT-LR ASSAY JPA INTERNATIONAL TECHNIDYNE CORP (ITC) JACT-LR (ASSAY) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention