BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2123568 · Received June 9, 2011

    Report

    Report Number
    2027969-2011-01282
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO2 METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, TIME: 11:15AM, PT'S INRATIO2: 4.0. PT SELF TESTER TESTED AT HOME. DATE: (B)(6) 2011, PT'S INRATIO2: 3.6, DOCTOR'S INRATIO: 2.8, LAB: 2.8. PT BROUGHT HER INRATIO2 METER TO HER DOCTOR'S OFFICE FOR A SIDE BY SIDE COMPARISON. NURSE DID FINGER STICK AND DROPPED BLOOD ON INRATIO METER, WIPED THE FINGER, THEN ADDED BLOOD DROP TO PT'S METER. PT WENT TO THE LAB WITHIN 30 MINUTES ON METER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1