BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1971340 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00428
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.2 INR ON THE COAGUCHEK XS SYSTEM AND 3.8 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 20182931

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR COLACE (DAILY)| LORAZEPAM (TWICE DAILY)| PRILOSEC (DAILY)| COUMADIN (DAILY)| LODIPINE (DAILY)| CELEXA (DAILY)| ALBUTEROL (DAILY)| METFORMIN (DAILY)| SIMVASTATIN (DAILY)| FLOVENT (DAILY)| SINGULAIR (DAILY)| CITRACAL D (DAILY)| MACROBID