BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2971276 · Received May 13, 2008

    Report

    Report Number
    2954730-2007-00607
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 12, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME OF COMPLAINT WAS FILE: DATE: (B)(6) 2008; INRATIO: 4.8; MEAN: 8.8; CONFIDENCE LIMITS: CAN NOT BE DETERMINED. ON (B)(6) 2008; 3.9; 11.3; 7.6; CONFIDENCE LIMIT CAN NOT BE DETERMINED. INRATIO: 1.8; 2.34; 2.07; 1.4-3.1. INRATIO: 2.0; 2.5; 2.25; 1.4-3.1. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. FOR THE FIRST AND SECOND SETS OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. FOR THE THIRD AND FOURTH SETS OF DATE, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS OF INR TESTING. THIS IS ADVERSE EVENT CASE. PRODUCT WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: ON (B)(6) 2008; INRATIO: 4.8; LAB: 12.8. ON (B)(6) 2008; 3.9; 11.3. INRATIO: 1.8 AND 2.0; LAB: 2.34 AND 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROBIN TIME TEST GJS HEMOSENSE, INC. 070415

    Patients

    Seq Age Sex Outcome Treatment
    1