BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2142862 · Received June 21, 2011

    Report

    Report Number
    2027969-2011-01379
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 LAB. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 5.2, 3.8. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. ON (B)(6) 2011, PT'S DOCTOR TOOK HIM OFF WARFARIN DUE TO INRATIO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other