BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123548 · Received June 9, 2011

    Report

    Report Number
    2027969-2011-01291
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 241836. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, LOT# 248203 INRATIO: 6.1, LOT# 241836 INRATIO: 4.0. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. RESULTS DONE WITHIN MINUTES OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 248203

    Patients

    Seq Age Sex Outcome Treatment
    1