BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 2093520 · Received April 6, 2011

    Report

    Report Number
    2248721-2011-00051
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 18, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKP
    PMA / PMN Number
    K951072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (CUVETTE LOTS K0P3C503, K0P3C497). METHOD: DEVICE HISTORY RECORD REVIEWED FOR NCMR AND CAPA. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULT: RECORD EVALUATION COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. DEVICE OPERATED ACCORDING TO SPECIFICATIONS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS THAT PROTIME MICROCOAGULATION SYSTEM GENERATED PATIENT RESULT HIGHER THAN REFERENCE. PROTIME MICROCOAGULATION SYSTEM GENERATED PT/INR RESULT OF GREATER THAN 9.9 ON THE SAME DAY LAB DRAW CLOTTED BEFORE LAB COULD PERFORM TEST. PATIENT WAS GIVEN 5 MG OF ORAL VITAMIN K AND COUMADIN WAS WITHHELD. THERE WAS NO SIGN OF BLEEDING FROM THE PATIENT. ON (B)(6) 2011, PT/INR LAB RESULT 1.59. QUALITY CONTROL TESTS PASSED. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME MICROCOAGULATION SYSTEM GKP INTERNATIONAL TECHNIDYNE CORP. PROPH110

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN