BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® S SYSTEM

    MDR report key: 1970579 · Received January 25, 2011

    Report

    Report Number
    1823260-2011-00395
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 5.8 INR ON THE COAGUCHEK S SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.0 INR. NO ACTIONS TAKEN BASED ON 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 STRIPS JPA ROCHE DIAGNOSTICS NA 933A

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR COUMADIN DAILY