BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1833463 · Received September 8, 2010

    Report

    Report Number
    2027969-2010-01380
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN TWO METERS AND THE LAB FOR THREE PATIENTS: PATIENT: 1, INRATIO1: 2.8, INRATIO2: 3.3, LAB: 3.4. PATIENT: 2, INRATIO1: 4.0, INRATIO2: 3.0. PATIENT: 3, INRATIO1: 2.2, INRATIO2: 1.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234589

    Patients

    Seq Age Sex Outcome Treatment
    1