BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCHRON JR. SIGNATURE PLUS SYSTEM

    MDR report key: 2092828 · Received May 11, 2011

    Report

    Report Number
    2248721-2011-00064
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 15, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY RECORD, NCMR, CAPA AND COMPLAINT HISTORY EVALUATED. NO PRODUCT RETURNED. RESULT: RECORD EVALUATION COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS DISCREPANT RESULTS WITH HEMOCHRON JR. SIGNATURE PLUS SYSTEM. PT/INR WITH HEMOCHRON JR. SIGNATURE PLUS SYSTEM 1.9. LAB GENERATED PT/INR 1.5 PT HAD A CVA ON (B)(6) 2011. ELECTRIC AND WET QUALITY CONTROLS WERE ACCEPTABLE PRIOR TO AND POST INCIDENT. PT'S THERAPEUTIC RANGE 2.0-3.0. THERAPEUTIC RANGE S/P CVA 2.5-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR. SIGNATURE PLUS SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. PSIG

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening