BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1942309 · Received December 22, 2010

    Report

    Report Number
    2027969-2010-02252
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" (B)(6) 2010, INR = 4.0; (B)(6) 2010, INR = 2.4. FOLLOW UP FROM PT: SHE DID LAB COMPARISON WITHIN 1HR OF METER TEST WITH NEW STRIP LOT 234526. METER 2.2 AND LAB 2.1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234526

    Patients

    Seq Age Sex Outcome Treatment
    1