BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK PT TEST STRIPS

    MDR report key: 509062 · Received January 28, 2004

    Report

    Report Number
    1823260-2003-00358
    Event Type
    Injury
    Date Received
    January 28, 2004
    Date of Event
    March 17, 2002
    Report Date
    March 27, 2003
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PROTHROMBIN TIME TESTED IN DOCTORS OFFICE. INR=2.3 IN 03/2002. THREE DAYS LATER, PT HAD A TIA AND WAS EVALUATED AT LOCAL HOSP ER. PROTHROMBIN TIME CHECKED AND INR=1.3. PT WAS NOT ADMITTED TO HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK PT TEST STRIPS PROTHROMBIN TIME TEST STRIPS JPA ROCHE DIAGNOSTICS NA 395

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening