BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2230947 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01599
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    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

    CUSTOMER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.3, RE-TEST: 1.3. RE-TEST DONE WITHIN 5 MINUTES. PT SPECIFICS: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251114

    Patients

    Seq Age Sex Outcome Treatment
    1