BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1913759 · Received November 23, 2010

    Report

    Report Number
    2027969-2010-02037
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO (LOT # 243699): 4.1, INRATIO (LOT # 234130): 1.8. USED TWO DIFFERENT FINGERS FOR EACH TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243699

    Patients

    Seq Age Sex Outcome Treatment
    1