BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1930386 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07502
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 27, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.7 INR ON THE COAGUCHEK XS SYSTEM AND 3.8 INR AT THE HOSPITAL. CALLER STATES THE PATIENT WAS SENT TO THE HOSPITAL BECAUSE OF A SEVERE BLOOD NOSY. CALLER STATES THE PATIENT'S NOSE WAS PACKED, HIS COUMADIN WAS HELD, AND HE RETURNED TO THE REHAB CENTER. 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 20182131

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR LOTREL| MULTIVITAMIN| COUMADIN (DAILY)| ZYPREXA| BACLOFEN| HYTRIN| GLUCOPHAGE| ZOLOFT