BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1770720 · Received September 5, 2007

    Report

    Report Number
    1823260-2007-07763
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    July 18, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PATIENT TESTED 4.5 INR ON THE COAGUCHEK S SYSTEM AND 3.0 INR ON A COMPARISON LAB. NO ACTION TAKEN BASED ON VALUES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM. HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 580A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA HYDROCODONE - AS NEEDED| SEENA S - TWICE DAILY| DIGOXIN - 0.25 MG DAILY| COUMADIN - 5 MG DAILY| IBUPROFEN - 600 MG AS NEEDED| COLCHICINE - 0.6 AS NEEDED| FERROUS SULFATE - DAILY| METOPROLOL - 25 MG TWICE DAILY| ASPIRIN EC - 81 MG DAILY| AMIODORARONE - 100 MG DAILY| OXYCODONE - 1-2 TABS AS NEEDED - EVERY 4 HOURS