BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1203647 · Received October 16, 2008

    Report

    Report Number
    1823260-2008-07666
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 1. REFERENCE MEDWATCH WITH A1 PT FOR SUSPECT DEVICE IN COAGUCHEK SYSTEM 2.

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED 1.6 INR ON COAGUCHEK SYSTEM 1, 1.6 INR ON COAGUCHEK SYSTEM 2, AND 2.8 INR ON A COMPARISON LAB. ALL RESULTS OBTAINED WITHIN 4 HOURS. MEDICATION INCREASED BASED ON LAB 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 STRIPS - JPA JPA ROCHE DIAGNOSTICS 740A-E7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIPITOR - 10 MG/DAILY| COUMADIN - 6-8 MG/DAILY| NEXIUM - 40 MG/DAY| NORVASC - 5 MG/DAILY