BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1770975 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09870
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K974569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 8.0 INR ON THE COAGUCHEK S SYSTEM AND 4.28 INR ON A COMPARISON LAB. PATIENT WAS TOLD TO HOLD COUMADIN UNTIL LAB RESULT RETURNED. ONCE THE LAB RESULT RETURNED, THE PATIENT WAS INSTRUCTED TO CONTINUE TO HOLD COUMADIN FOR A 'FEW MORE DAYS'. 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 COAGUCHEK S SYSTEM PROTHROMBIN TIME TEST STRIPS - JPA JPA ROCHE DIAGNOSTICS 600A-B10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BUSPAR, 10 MG/DAY| POTASSIUM, 10 MEQ/DAY| OMEPRAZOLE, 20 MG/DAY| KLONOPIN, 1MG/DAY| LASIX, 20 MG/DAY| FELODIPINE, 5MG/DAY| COUMADIN, 7.5 MG/DAY| GLIPIZIDE, 10 MG/DAY