BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3082622 · Received April 23, 2013

    Report

    Report Number
    2027969-2013-00332
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ALERE SAN DEIGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 INR RESULTS IN COMPARISON TO THE PHYSICIAN'S UNSPECIFIED POINT OF CARE (POC) INR METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 1.6; POC METER: 2.4. THE TIME BETWEEN TESTING WAS ONE MINUTE AND A REPEAT FINGER STICK WAS PERFORMED ON THE SAME FINGER. THE PT'S THERAPEUTIC RANGE WAS NOT PROVIDED. THERE WAS NO REPORTED AVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174763 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DEIGO, INC. 100071 299622

    Patients

    Seq Age Sex Outcome Treatment
    1