BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR SIGNATURE SYSTEM

    MDR report key: 2057955 · Received March 9, 2011

    Report

    Report Number
    2248721-2011-00032
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 10, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K940401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: MANUFACTURER/EVALUATION/INVESTIGATION CURRENTLY IN PROCESS. ACTUAL DEVICE INVOLVED IN COMPLAINT WAS EVALUATED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    PATIENT 1 OF 2. HEALTHCARE PROFESSIONAL REPORTS HEMOCHRON JR SIGNATURE SYSTEM DISCREPANCY SINCE SWITCHING CUVETTE LOT. PT/INR 9.2, LAB PT/INR 2.8. PATIENT TREATMENT WAS BASED ON THE LAB PT/INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0. PATIENT IS ON ANTICOAGULATION REGIMEN OF BOTH COUMADIN AND LOW MOLECULAR WEIGHT HEPARIN. ALL LIQUID QUALITY CONTROL TESTS HAVE BEEN ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR SIGNATURE SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. HEM JR-CUVET FG H0JPT081

    Patients

    Seq Age Sex Outcome Treatment
    1 LOVENOX| COUMADIN