BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1849759 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01568
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH FIRST METER COMPARED TO A SECOND METER. PATIENT #2. (B)(6) 2010; INRATIO METER #1 - 5.1; (USED LOT #232171). ON (B)(6) 2010; INRATIO METER #1 - 4.9; INRATIO METER #2 - 3.6; (USED LOT#228136).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232171

    Patients

    Seq Age Sex Outcome Treatment
    1