BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1931562 · Received December 17, 2010

    Report

    Report Number
    1823260-2010-07538
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 29, 2010
    Report Date
    December 17, 2010
    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). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 20181332, EXPIRATION DATE 12/31/2011). (B)(6).

    Description of Event or Problem · 1

    CALLER TESTED 4.0 INR, 4.2 INR, AND 4.4 INR INR ON COAGUCHEK XS SYSTEM 1 AND 2.5 INR, 2.5 INR, AND 2.5 INR ON COAGUCHEK XS SYSTEM 2. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20181332

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR WAFARIN DAILY| PARACETAMOL AM/PM