BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2070758 · Received April 14, 2011

    Report

    Report Number
    2027969-2011-00834
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.4, LAB: 2.8 (VENOUS SAMPLE). TESTING OCCURRED SAME DAY WITHIN 30 MINUTES. PATIENT'S TARGET RANGE IS BETWEEN (3.0-3.5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 246050

    Patients

    Seq Age Sex Outcome Treatment
    1 NI