BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1771966 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08160
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PATIENT TESTED 6.7 INR ON THE COAGUCHEK S SYSTEM AND 3.8 INR ON A COMPARISON LAB. MEDICATIONS WERE ADJUSTED BASED ON LAB VALUE. 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 589A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA COREG 25 MG DAY| TRICOR 160 MG DAY| COUMADIN 45 MG WEEKLY| LIPITOR 40 MG DAY| ZETIA 10 MG DAY| DIURETIC 25 MG DAY| POTASSIUM 10 MEQ DAY