BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1971341 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00426
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 12, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE COAGUCHEK XS SYSTEM USED. (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/COAGUCHEK S RESULTS WERE OBTAINED: 5.0 INR/3.5 INR. 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 20102911

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR IRON| COUMADIN (WEEKLY)