BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1972976 · Received January 20, 2011

    Report

    Report Number
    2027969-2011-00149
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) 2010, INRATIO: 4.9, LAB: 2.70. LAB DRAWN WITHIN 10 MINUTES OF THE INR READING. LAB PROCESSED SAMPLE WITHIN 4 HOURS. CALLER REPORTS USING HEPARIN-COATED CAP TUBES FOR THE LDX INSTEAD OF THE MICROSAFE TUBES FOR INRATIO AND ALWAYS WIPING THE FIRST DROP OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 235738

    Patients

    Seq Age Sex Outcome Treatment
    1