BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1873700 · Received October 13, 2010

    Report

    Report Number
    2027969-2010-01717
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 1.5. INR: 2.3. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR. CALL ALSO REPORTED 411 ERRORS ON ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235738

    Patients

    Seq Age Sex Outcome Treatment
    1 NI