BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1971347 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00436
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 5, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES SHE TESTED 2.4 INR ON THE COAGUCHEK XS SYSTEM AND 1.8 INR ON A COMPARISON LAB. CALLER STATES THE DOCTOR USED THE LAB RESULTS TO INCREASE HER COUMADIN DOSAGE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. CALLER STATES THAT THEY MAY HAVE SQUEEZED THE FINGER EXCESSIVELY AND THAT THEY MAY HAVE DOSED THE METER TOO QUICKLY. 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 20102911

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR METOPROLOL| NORVASC| COUMADIN