BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1812648 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05016
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.3 INR/1.8 INR. THE CALLER REPORTS THAT SHE MAY HAVE CONFUSED THE RESULTS AND THE ACTUAL COAGUCHECK XS/LABORATORY RESULTS MAY HAVE BEEN: 1.2 INR/1.8 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 20178031

    Patients

    Seq Age Sex Outcome Treatment
    1