BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR. SIGNATURE PLUS SYSTEM

    MDR report key: 2432909 · Received January 11, 2012

    Report

    Report Number
    2248721-2012-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 15, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUVETTE LOT WAS NOT PROVIDED. ACTUAL DEVICE NOT EVALUATED. MFG REVIEW PERFORMED. DEVICE HISTORY RECORD REVIEWED. NO RELATED NCMRS, COMPLAINT TRENDS OR CAPA IDENTIFIED. NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED. UNABLE TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. 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. DURING AN UNSPECIFIED PROCEDURE INSTRUMENT GENERATED ACT-LR RESULT >400 SECONDS. ACT-LR RESULTS REPEATED WITH SECOND INSTRUMENT WAS ABOUT 70 SECONDS LOWER. NO ADVERSE EVENT(S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1