BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2222653 · Received August 25, 2011

    Report

    Report Number
    1823260-2011-04552
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.3 INR ON THE COAGUCHEK XS SYSTEM AND 1.8 INR ON A COMPARISON LAB. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 20131222

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR SPIRONOLACTONE (DAILY)| SIMVASTATIN (DAILY)| WARFARIN (DAILY)| FUROSEMIDE (TWICE DAILY)| METOPROLOL XL (DAILY)| DEFIBRILLATOR| LISINOPRIL (DAILY)| ASPIRIN (DAILY)| GLIPIZIDE (TWICE DAILY)| STENT