BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1060049 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04675
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED >8.0 INR AND 6.2 INR ON THE COAGUCHEK S SYSTEM DURING DUPLICATE TESTING. NO TREATMENT INFO PROVIDED. 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 683A-F2

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR IMDUR| VICODIN| COUMADIN 5MG/DAY| PLAVIX| PROTONIX| AMBIEN| TOPROL