BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1902098 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06809
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.2 INR ON THE COAGUCHEK XS SYSTEM AND 1.2 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.CALLER STATES THAT THE STRIP VIAL WAS 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 20181121

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR FLECAINIDE| COUMADIN| ZANTAC| ZOLOFT