BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1923872 · Received December 8, 2010

    Report

    Report Number
    2027969-2010-02132
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 8, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: PATIENT 1, DATE: (B)(6) 2010, INRATIO: 7.5, LAB: 3.94. PATIENT 2, INRATIO: 3.1, LAB: 2.2. CUSTOMER REPORTS DISCREPANT HIGH RESULTS IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232888

    Patients

    Seq Age Sex Outcome Treatment
    1 NI