BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR.SIGNATURE MICROCOAGULATION SYSTEM

    MDR report key: 1994711 · Received January 12, 2011

    Report

    Report Number
    2248721-2011-00011
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 14, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE AGE OF THE INSTRUMENT AND POTENTIAL INABILITY TO SERVICE DUE TO PARTS UNAVAILABILITY (MODEL HAS NOT BEEN MANUFACTURED FOR SEVERAL YRS), CUSTOMER REPORTED PLANS TO ORDER A NEW MODEL AND DOES NOT INTEND TO RETURN THE DEVICE. METHOD, RESULT: NO PRODUCT RETURNED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LOWER THAN EXPECTED RESULTS FOR ACT+ WHEN TESTED ON HEMOCHRON SIGNATURE INSTRUMENT. CUSTOMER REPORTED GETTING ACT+ ASSAY RESULTS IN THE CARDIAC CATH LAB FOR A PT AROUND 120-130 SECONDS ON THE HEMOCHRON SIGNATURE INSTRUMENT REGARDLESS OF THE AMOUNT OF HEPARIN ADMINISTERED. ACT RESULTS WERE 123, 125, 122, AND 121 SECONDS ON THE HEMOCHRON SIGNATURE VS 310 SECONDS ON A SIGNATURE ELITE. THE TARGET WAS GREATER THAN 200 SECONDS. THERE WAS NO DELAY IN THE PROCEDURE. NO ADVERSE EVENTS REPORTED. NO TESTING OF PT FOR HEPARIN RESISTANCE. ELECTRICAL QUALITY CONTROL WAS RUN PRIOR TO THE PROCEDURE AND PASSED. CUSTOMER REPORTED THAT SHE HAS BEEN RUNNING CONTROLS REGULARLY ON THE INSTRUMENT AND ALL RESULTS WERE IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR.SIGNATURE MICROCOAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORPORATION HE-SIG

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR HEPARIN