BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1946284 · Received January 4, 2011

    Report

    Report Number
    1823260-2011-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 28, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 5.8 INR ON THE COAGUCHEK XS SYSTEM AND 4.2 INR ON A COMPARISON LAB. CALLER STATES THE PATIENT'S COUMADIN WAS HELD FOR THE DAY AND REDUCED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20131011

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR POTASSIUM CHLORIDE| MAGNESIUM OXIDE| CREON| COUMADIN| PROTONIX| SANDOSTATIN| ZOFRAN| IMODIUM