BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2083428 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02498
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT SHE TESTED 4.8 INR AND 4.9 INR ON THE COAGUCHEK XS SYSTEM AND 3.3 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 ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20131223

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR COUMADIN (DAILY)| SIMVASTATIN (DAILY)