BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCHRON SIGNATURE MICROCOAGULATION SYSTEM

    MDR report key: 1897704 · Received November 4, 2010

    Report

    Report Number
    2248721-2010-00159
    Event Type
    Death
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON 11/04/2010 REFERENCES ITC COMPLAINT (B)(4). PATIENT DEATH WAS NOT DUE TO THE INSTRUMENT IN THIS REPORT. CUSTOMER INDICATED POST EVENT QUALITY CONTROL RESULTS DEMONSTRATED PROPER PERFORMANCE. MANUFACTURER AWAITING PRODUCT RETURN FOR FURTHER COMPLAINT EVALUATION. THERE ARE 2 STAGES TO DIC. IN THE EARLY STAGE, THERE IS WIDESPREAD ACTIVATION OF CLOTTING FACTORS. AT THIS STAGE, ACT IS EXPECTED TO BE VERY SHORT. AS DIC PROGRESSES, CLOTTING FACTORS ARE CONSUMED AND ANTI-CLOTTING FACTORS BECOME ACTIVATED. AT THIS STAGE, ACT IS TYPICALLY MARKEDLY PROLONGED. THE ACTS OBSERVED IN THIS COMPLAINT ARE CONSISTENT WITH THE 2 PHASES OF DIC, AND THEREFORE, THE (B)(4) OF ITC'S MEDICAL ADVISORY BOARD STATES THE INSTRUMENT PERFORMED AS EXPECTED. ITC COMPLAINT CASE ADDITIONAL REFERENCE: CASE (B)(4), MDR #2248721-2010-00150; CASE (B)(4), MDR #2248721-2010-00158; CASE (B)(4), MDR #2248721-2010-00159, CASE (B)(4), MDR #2248721-2010-00160. CUVETTE LOT #'S: G0JAC204, G0JAC118, E0JAC143. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    DEVICE 3 OF 4. CUSTOMER REPORTED VARIED RESULTS: OUTSIDE-REPORTABLE-RANGE-LOW, LOW ACT AND HIGH ACT RESULTS WITH THE SIGNATURE ELITE INSTRUMENT. TESTING TIME POINTS NOT SPECIFIED AND SPECIFIC INSTRUMENTS AND CUVETTE LOT NUMBERS NOT IDENTIFIED. NOTE: ONE MDR REPORTED FOR EACH SYSTEM SERIAL NUMBER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death