BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 3123888 · Received May 15, 2013

    Report

    Report Number
    2248721-2013-00027
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TESTING WAS PERFORMED USING ACT TUBE LOT# M2FTE299. METHOD CODE: ACTUAL DEVICE EVALUATED (INSTRUMENT). RESERVE SAMPLE TESTED FROM THE SAME LOT (ACT TUBE/SINGLE-USE DISPOSABLE). PROCESS EVAL PERFORMED. NO RELATED NCMRS IDENTIFIED FOR THIS INSTRUMENT. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. RESULT CODE: COMPLAINT WAS NOT CONFIRMED THROUGH THE INSTRUMENT AND ACT TUBE EVAL. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS INCONSISTENT ACT RESULTS WITH THE HEMOCHRON RESPONSE COAGULATION SYSTEM. DURING A PROCEDURE IN THE CARDIAC BY-PASS UNIT, ACT RESULTS WERE INCONSISTENT WHEN COMPARING BLOOD SAMPLES RAN USING BOTH HEMOCHRON RESPONSE TEST WELLS. CUSTOMER PROVIDED THE FOLLOWING EXAMPLES OF THE RESULTS: SEE SCANNED TABLE. TARGET TIME WAS NOT PROVIDED. NO ADVERSE EVENT (S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215076 HEMOCHRON RESPONSE COAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. HRS.110

    Patients

    Seq Age Sex Outcome Treatment
    1