BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1813435 · Received August 19, 2010

    Report

    Report Number
    2027969-2010-01243
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATING PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WHILE PERFORMING A CORRELATION STUDY. DATA SET (1.7, 2.6, 3.9) - IMMEDIATE RE-TEST WAS PERFORMED ON A DIFFERENT FINGER. WITHIN FIVE MINUTES A LAB DRAW WAS PERFORMED. DATA SET (1.4, 2.5) - IMMEDIATE RE-TEST WAS PERFORMED ON A DIFFERENT FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232887

    Patients

    Seq Age Sex Outcome Treatment
    1