BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2980884 · Received February 27, 2013

    Report

    Report Number
    1823260-2013-01191
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 6.2 INR ON THE COAGUCHEK XS PLUS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.9 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER CALL NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85520 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR ENALAPRIL| WARFARIN| SIMVASTATIN| ADALAT LA