BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1910073 · Received November 30, 2010

    Report

    Report Number
    1823260-2010-07055
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    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

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES THAT HE TESTED 3.8 INR ON THE COAGUCHEK XS SYSTEM AND 2.9 INR ON THE COMPARISON LAB. CALLER STATES THAT HIS TREATMENT WAS TO LEAVE HIS COUMADIN DOSAGE THE SAME AS IT WAS BASED ON THE LAB RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. CALLER STATED THAT THE STRIP VIAL IS EMPTY, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR WARFARIN| CELEBREX