BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1851595 · Received September 28, 2010

    Report

    Report Number
    2027969-2010-01593
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER. DOCTOR INCREASED PATIENTS COUMADIN DOSAGE BY 1 MG ON (B)(6) 2010. CALLERS HUSBAND REPORTS THAT HE HAS TO POKE FINGER 2-3X EACH TIME TO GET BLOOD OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 226218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other