BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOAGUCHEK S SYSTEM

    MDR report key: 1012442 · Received March 13, 2008

    Report

    Report Number
    1823260-2008-02398
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED >8.0 INR ON THE COAGUCHEK S SYSTEM AND 4.0 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCOAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 654A-F13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HYZAAR 100-25| ZOLOFT - 50MG/DAY| ALBUTEROL| SINGULAIR 10MG/DAY| DIGITEK 0.125MG/DAY| COUMADIN 6MG MF| PRILOSEC - 20MG/DAY| REGLAN - 100MG/DAY| POTASSIUM - 20MEQ/DAY| NAPROXEN - 500MG/DAY| VITAMIN B12 - 100MCG/DAY| ADVAIR| LASIX - 40MG/DAY| VITAMIN D| CARDIZEM - 360MG/DAY