BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3019078 · Received March 19, 2013

    Report

    Report Number
    2027969-2013-00230
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 4.3, LAB: 17.0. TIME BETWEEN TESTING WAS REPORTED AS 1 HOUR. PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0. IT WAS REPORTED THE PATIENT WENT TO THE HOSPITAL BECAUSE SHE FELT THAT HER BLOOD WAS THIN. AT THE HOSPITAL, SHE WAS GIVEN AN UNSPECIFIED AMOUNT OF VITAMIN K TO HELP LOWER HER INR. ALERE WAS UNABLE TO OBTAIN FURTHER INFORMATION REGARDING RESULTS OF HOSPITAL VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113739 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 299629

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R COUMADIN