BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 2460873 · Received February 13, 2012

    Report

    Report Number
    2248721-2012-00015
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 1, 2011
    Report Date
    January 16, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER PROVIDED CUVETTE LOT# H1JCC015. ACTUAL DEVICE NOT EVALUATED. PROCESS EVAL PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECS. NO RELATED NCMRS, COMPLAINT TRENDS, OR CAPA IDENTIFIED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS RESULTS HIGHER THAN REFERENCE WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM WHILE RUNNING CITRATED APTT CUVETTES OVER THE PAST SEVERAL MONTHS. CUSTOMER REPORTED EXAMPLES OF THE OBSERVED DISCREPANCY. EXAMPLE 1 OF 2: CITRATED APTT TEST GENERATED RESULT OF 160 PLASMA EQUIVALENT SECONDS (PES) AND LAB RESULT GENERATED LAB RESULT OF 77 PES. EXAMPLE 2 OF 2 FILED ON MFR REPORT# 2248721-2012-00016. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1