BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2121328 · Received May 5, 2011

    Report

    Report Number
    2027969-2011-00994
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" INITIAL 1.2; REPEAT 2.5, 2.3. CUSTOMER IS HAPPY WITH 2.5 VS 2.3 PRECISION, BUT IS NOT SURE WHY THE FIRST RESULT WAS SO LOW. THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 NG

    Patients

    Seq Age Sex Outcome Treatment
    1