BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK PT TEST STRIPS

    MDR report key: 514485 · Received January 20, 2004

    Report

    Report Number
    1823260-2004-00026
    Event Type
    Malfunction
    Date Received
    January 20, 2004
    Date of Event
    January 9, 2004
    Report Date
    January 9, 2004
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO PTS TESTED ON SUSPECT METER. BOTH PT'S INR=>8.0 ON SUSPECT METER. LAB RESULT, INR 5.6 AND 6.0. BOTH PTS WERE GIVEN VITAMIN K. NO ADVERSE EVENTS REPORTED. CONTROLS WERE REPORTED IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK PT TEST STRIPS PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 689

    Patients

    Seq Age Sex Outcome Treatment
    1 *