BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE MICROCOAGULATION SYSTEM

    MDR report key: 1900230 · Received October 25, 2010

    Report

    Report Number
    2248721-2010-00152
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    September 29, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR AWAITING PRODUCT RETURN FOR FURTHER COMPLAINT EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INTERMITTENT UNEXPECTED INCREASES IN ACT+ FROM APPROX 420 TO > 1000. THIS EVENT HAS OCCURRED MULTIPLE TIMES WITH THE NEED TO REPEAT THE TEST IN EACH CASE. NO ADVERSE EVENTS REPORTED.

    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