BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1780357 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07955
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 9, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PT TESTED 2.6 INR ON THE COAGUCHEK S SYSTEM AND 1.9 INR ON A COMPARISON LAB. NO ACTION TAKEN BASED ON VALUES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 577A-B11

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR THYROID MEDICATION| SINGULAIR| COUMADIN - 5MG/DAY| ADVAIR| HCTZ| ALBUTEROL| NEXIUM