BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTIME MICROCOAGULATION SYSTEM

    MDR report key: 3834532 · Received March 19, 2014

    Report

    Report Number
    2248721-2014-00010
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K961835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE ACTUAL DEVICE WAS NOT EVALUATED. PROCESS EVALUATION WAS PERFORMED. NO RELATED NCMRS WERE IDENTIFIED FOR THIS INSTRUMENT. THE CUVETTE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATION. RESULT: NO RESULTS ARE AVAILABLE SINCE NO EVALUATION WAS PERFORMED. CONCLUSION: THE DEVICE WAS NOT RETURNED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    A PT SELF-TESTER REPORTS INCONSISTENT RESULTS WERE GENERATED WITH THE PROTIME MICROCOAGULATION SYSTEM. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. THE PT SELF-TESTER'S PROTIME INSTRUMENT GENERATED A RESULT OF 4.3 INR. HE STATED HIS INR IS USUALLY PRETTY STABLE. UPON AN ATTEMPTED REPEAT TEST, TWO INSTRUMENT ERROR MESSAGES WERE RECEIVED, "SAMPLE TOO LARGE" AND "SAMPLE NOT SEEN". THEN, A 1.0 INR WAS GENERATED DURING THE REPEAT TEST. THE FOLLOW UP REFERENCE LAB RESULT GENERATED A 2.4 INR. NO ADVERSE EVENTS WERE REPORTED; THE REFERENCE LAB RESULTS WERE USED FOR PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162615 PROTIME MICROCOAGULATION SYSTEM PROTHROMBIN TIME TEST GJS INTERNATIONAL TECHNIDYNE CORP. PROTIMEPST

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR