BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2121277 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03201
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 2, 2011
    Report Date
    September 29, 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

    Description of Event or Problem · 1

    CALLER STATES SHE TESTED 3.6 INR ON THE COAGUCHEK XS SYSTEM AND 2.7 INR ON A COMPARISON LAB. CALLER STATES THAT HER COUMADIN WAS REDUCED BASED ON THE LAB. NO OTHER 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 20306224

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR FLONASE (DAILY)| CLONAZEPAM (3 TIMES DAILY)| MORPHINE (AS NEEDED)| MS CONTIN (3 TIMES DAILY)| "IMPLANTED BATTERY FOR INCONTINENCE"| VALIUM (AS NEEDED)| COUMADIN| DIFLUCAN (AS NEEDED)| DILAUDID (AS NEEDED)| VICODIN (AS NEEDED)| SOMA (AS NEEDED)| EFFEXOR (DAILY)| PROAIR INHALER (AS NEEDED)| IMITREX (AS NEEDED)| AMITRIPTYLINE (NIGHTLY)| FUROSEMIDE (DAILY)| RANITIDINE (TWICE DAILY)| NEXIUM (TWICE DAILY)