BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1833321 · Received September 9, 2010

    Report

    Report Number
    2027969-2010-01396
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: DATE: (B)(6) 2010; INRATIO: 4.2; LAB: 3.1. DATE: (B)(6) 2010; INRATIO: 3.5; LAB: 2.8; INRATIO (NEW STRIPS): 3.2. TEN MINUTES IN BETWEEN METER AND LAB TESTING ON (B)(6) 2010. TESTING ON (B)(6) 2010 WAS DONE WITHIN MINUTES AT THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 225938

    Patients

    Seq Age Sex Outcome Treatment
    1