BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1860019 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-06011
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 2, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT SHE TESTED 3.8 INR ON THE COAGUCHEK XS SYSTEM AND 2.6 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 20181124

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR "HARDWARE IN BACK"| AMANTADINE (DAILY)| CALCIUM (3 TIMES DAILY)| CENTRUM SILVER| TYLOX (AS NEEDED)| VITAMIN D (4 TIMES DAILY)| VITAMIN B COMPLEX| COUMADIN (DAILY)| ST. JOHN'S WORT (DAILY)| POTASSIUM (DAILY)| MOBIC (DAILY)| ARTIFICIAL KNEE| ALBUTEROL (DAILY)| PHENDIMETRAZINE (DAILY)