BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1055814 · Received June 2, 2008

    Report

    Report Number
    2954730-2008-00400
    Event Type
    Injury
    Date Received
    June 2, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 29, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070615: FIRST TEST INR = 5.9, SECOND TEST INR = 3.8, MEAN = 4.85 ; SD = 01.48; %CV = 31%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN RETURNED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2008. INRATIO: 5.9, 3.8. LAB: 8.0, 8.0, MEAN: 6.95, 5.9, CONFIDENCE LIMITS: CANNOT BE DETERMINED, CANNOT BE DETERMINED. DATE: 2008. INRATIO: 4.1, 3.6. LAB: 4.4, 4.4. MEAN: 4.25, 4.0. CONFIDENCE LIMITS: 2.4-6.1, 2.3-5.7, PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST TWO SETS OF DATA, THE CONFIDENCE LIMITS FOR INR TESTING CANNOT BE DETERMINED. PER TEXT" DOCTOR SENT HIM TO ER WHERE THEY GAVE HIM VITAMIN K AND HE IS FINE NOW." THIS IS ADVERSE EVENT CASE. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 5.9, SECOND TEST INR = 3.8. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2008, INRATIO: 5.9, 3.8 LAB: 8.0, 8.0; DATE: 2008, INRATIO: 4.1, 3.6. LAB: 4.4, 4.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070615

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization