BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2251720 · Received August 31, 2011

    Report

    Report Number
    2027969-2011-01904
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 31, 2011
    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 USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO:0.8, RE-TEST: 3.1. TESTING WAS DONE USING DIFFERENT HANDS, WITHIN A FEW MINUTES OF EACH OTHER. CUSTOMER REPORTS WIPING THE FIRST DROP AND USING THE SECOND HANGING DROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251115

    Patients

    Seq Age Sex Outcome Treatment
    1