BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® S SYSTEM

    MDR report key: 1778227 · Received July 31, 2010

    Report

    Report Number
    1823260-2010-04443
    Event Type
    Malfunction
    Date Received
    July 31, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 5.6 INR ON THE COAGUCHEK S SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.1 INR. PATIENT WAS TREATED WITH VITAMIN K. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR COUMADIN