BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780364 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07957
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 13, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K994349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS PT TESTED 8.8 INR AND "9 SOMETHING" ON THE COAGUCHEK S SYSTEM. COUMADIN HELD FOR 9 DAYS BASED ON SERIES OF HIGH INR RESULTS FOR SEVERAL DAYS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT INSTRUMENT AND REPLACEMENT SENT. NUMERIC READING RANGE OF DEVICE IS 0.6 INR TO >8.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME MONITOR - JPA JPA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA COUMADIN - 5MG/DAY| COUMADIN - 7.5MG/DAY