BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1833083 · Received September 9, 2010

    Report

    Report Number
    2027969-2010-01386
    Event Type
    Other
    Date Received
    September 9, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    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) 2010, INRATIO: 2.1; DATE: (B)(6) 2010, INRATIO: 2.2, LAB: 8.0. PER CUSTOMER, PT TESTED AT HOME ON (B)(6) 2010 BY HOME HEALTH NURSE AND OBSERVED INR =2.1. PT HAD INTERIOR HIP REPAIR AND LEG STARTED SWELLING. RETESTED ON (B)(6) 2010 AND OBSERVED INR=2.2. LEG SWELLING HAD INCREASED. PT SENT TO HOSPITAL ER. LAB INR=8.0. TESTING PERFORMED WITHIN 1-1 1/2 HOURS OF METER TESTING. NEW PT. NO INR HISTORY WITH METER. THERAPEUTIC RANGE = 2.0-3.0. HOSPITAL DETERMINED SWELLING WAS DUE TO LARGE HEMATOMA. F/U FROM CUSTOMER. CUSTOMER REPORTS THAT PT'S HCT LEVEL WAS 18% WHEN ADMITTED TO THE HOSPITAL. CUSTOMER PERFORMED A SMALL CORRELATION STUDY WITH LAB: METER IN QUESTION: PT1 1.5 (PT 14.8); 2ND METER: 1.2; LAB: 1.5 (PT 14.3). METER IN QUESTION: PT2 1.4 (PT 13.6); 2ND METER: 1.2; LAB: 1.3 (PT 12.3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other