BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 2460893 · Received February 13, 2012

    Report

    Report Number
    2248721-2012-00016
    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. METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVAL PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. NO RELATED NCMRS, COMPLAINT TRENDS, OR CAPA IDENTIFIED. RESULT: UNABLE TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTH 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 2 OF 2: CITRATED APTT TEST GENERATED RESULT OF 46 PLASMA EQUIVALENT SECONDS (PES) AND LAB RESULT GENERATED LAB RESULT OF 29 PES. EXAMPLE 1 OF 2 FILED ON MFR REPORT# 2248721-2012-00015. 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