BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2177927 · Received July 26, 2011

    Report

    Report Number
    1823260-2011-04000
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER TESTED 3.0 INR ON THE COAGUCHEK XS SYSTEM. AN UNSPECIFIED TIME LATER CALLER WAS UNABLE TO SPEAK PROPERLY AND WAS TAKEN TO THE HOSPITAL WHERE A COMPARISON LAB RETURNED AS 1.96 INR APPROXIMATELY 2 HOURS AFTER THE METER RESULT. CALLER WAS DIAGNOSED WITH A MINOR CEREBRAL VASCULAR ACCIDENT (CVA) IN THE THALAMUS. CALLER WAS TREATED WITH HEPARIN IV AND RELEASED FROM THE HOSPITAL 13 DAYS LATER. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER CALLER NO LONGER HAS THE TEST STRIPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR BISOPROLOL| MAVIK| SYNTHROID| PACEMAKER| MECHANICAL "VALVE"| "PRO-ASA"| FUROSEMIDE| CALCIUM| COUMADIN| CRESTOR| "EURO-K"