BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3042285 · Received April 3, 2013

    Report

    Report Number
    2027969-2013-00277
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULT. RESULTS AS FOLLOWS: DATE: (B)(6) 2013; INRATIO INR: 1.2, 3.2 AND 3.1. THE TIME BETWEEN TESTING WAS FIVE MINUTES AND THE PT DID NOT USE THE FIRST DROP OF BLOOD ON THE FIRST TEST, RESULTING IN AN INR OF 1.2. ADDITIONALLY, THE PT REC'D AN UNSPECIFIED ERROR HOWEVER, WAS NOT ABLE TO PROVIDE ANY ADD'L INFO REGARDING THE ERROR. THE LOT NUMBER WAS NOT PROVIDED AS THE PT DISCARDED THE STRIPS AND PACKAGE. THERAPEUTIC RANGE 2.0 - 3.0 FOR PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136084 INRATIO PROTHEROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN