BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2230932 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01595
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE DOCTOR'S POINT-OF-CARE (POC). RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 4.0, POC: 3.1. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR. HISTORICALLY, PATIENT IS AROUND 2.8 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 NI