BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2231608 · Received September 1, 2011

    Report

    Report Number
    1823260-2011-04699
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED >8.0 INR ON THE COAGUCHEK PLUS XS SYSTEM AND 2.8 INR ON A COMPARISON LAB. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR SIMVASTATIN| AMLODIPINE| WARFARIN