BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® S SYSTEM

    MDR report key: 1904301 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06899
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 10, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 5.2 INR AND 5.2 INR ON THE COAGUCHEK S SYSTEM AND 3.0 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® S SYSTEM PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 948A

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN