BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO 2

    MDR report key: 2221234 · Received August 15, 2011

    Report

    Report Number
    2027969-2011-01821
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 10, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER (PATIENT'S WIFE) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR. ON (B)(6) 2011, PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA) AND ENDED UP IN THE HOSPITAL FOR A WEEK. PATIENT WENT HOME ON (B)(6) 2011. THE METER AT THE TIME BEFORE THE HOSPITAL WAS READING WITHIN HIS RANGE. PATIENT RECEIVED HEPARIN AND LOVENOX IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO 2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 254609

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O