BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2142865 · Received June 21, 2011

    Report

    Report Number
    2027969-2011-01380
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    October 10, 2010
    Report Date
    June 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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; INRATIO2: 2-3; LAB: 4.2. DATE: (B)(6) 2011; INRATIO2: 2.4; LAB: 5.8. PT'S THERAPEUTIC RANGE: 2-3 INR. ON (B)(6) 2010, PT WENT TO THE EMERGENCY ROOM AND HAD BLEEDING AT OR NEAR THE KIDNEY. HE BLED INTO A PRE-EXISTING CYST ON THE KIDNEY. THE BLOOD ENDED UP OBSCURING A CAT SCAN AND ALMOST RESULTED IN THE REMOVAL OF THE ONLY REMAINING KIDNEY. ON(B)(6) 2011, PT WENT TO THE EMERGENCY ROOM HAVING PROBLEMS ABOVE THE LEFT ELBOW, WHICH STARTED 4 DAYS PRIOR. SHOULDER IS ALREADY ARTHRITIC. INITIALLY, ELBOW WAS HURTING, THEN STARTED TO SWELL. SWELLING WENT DOWN, BUT LATE EVENING ON (B)(6) 2011, PAIN IN ELBOW RESUMED AND WAS EXTREMELY EXCRUCIATING. AT THE EMERGENCY ROOM, PT HAD AN INCREASED SHOT OF HYDROCORTISONE. PT HAD A STRESS DOSE OF HYDROCORTISONE OVER THE WEEKEND PRIOR TO RESULTS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O| R