BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOADGULATION SYSTEM

    MDR report key: 2479625 · Received February 27, 2012

    Report

    Report Number
    2248721-2012-00022
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 30, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER TESTED USING INSTRUMENT SERIAL NUMBER (B)(4). METHOD: CUSTOMER RETURNED SAMPLES WERE EVALUATED (SINGLE-USE DISPOSABLE). TEST PERFORMED AS EXPECTED. TEST WITH NORMAL DONOR BLOOD WAS WITHIN ALLOWABLE QC RANGE AND TEST WITH NORMAL DONOR BLOOD SPIKED WITH HEPARIN GENERATED AN EXPECTED HEPARIN RESPONSE. RESERVED SAMPLE TESTED FROM SAME LOT. BATCH RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    PT 2 OF 3. HEALTH PROFESSIONAL REPORTS RESULTS OUTSIDE REPORTABLE RANGE HIGH WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM WHILE RUNNING CITRATED APTT CUVETTES. DURING AN EMERGENCY ROOM EVAL TO RULE OUT STROKE FOR THREE PTS, TESTS GENERATED APTT RESULTS OF >250 PLASMA EQUIVALENT SECONDS (PES) AND REPEAT TESTS GENERATED >250 PES. LAB GENERATED RESULTS OF 31-33 PES. SYSTEM PASSED LIQUID QUALITY CONTROL. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOADGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. J1JCC021

    Patients

    Seq Age Sex Outcome Treatment
    1