BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780163 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08297
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 6, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED 7.2 INR ON THE COAGUCHEK S SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.78 INR. PT WAS SENT TO HOSP FOR A VITAMIN K SHOT DUE TO DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIP - JPA JPA ROCHE DIAGNOSTICS 599A-G7

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR NITROFURANTOIN - 200MG/DAY| HYOSCYAMINE - .15MG/4PER/DAY| DILTIAZEM - 180MG/DAY| LORTAB - 5-500MG/ 4/DAY| COUMADIN - 2.5MG/DAY| ALTASE - 10MG/DAY