BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 850781 · Received March 9, 2007

    Report

    Report Number
    2954730-2007-00115
    Event Type
    Malfunction
    Date Received
    March 9, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 6, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060638: FIRST TEST INR = 7.2; SECOND INR = 7.5; MEAN = 7.35; SD = 0.21; %CV=2.9%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. TS UPDATED THIS CASE ON 03/01/2007. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007, INRATIO: 7.2, LAB: 9.5, MEAN: 8.35, CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS CANNOT BE DETERMINED. BOTH INRATIO AND LAB RESULTS WERE > 5.0. PER THE VALUES DID'T CONSIDERED INACCURATE. NO FURTHER TESTING REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 7.2 SECOND TEST INR = 7.5. TECHNICAL SUPPORT UPDATED THIS CASE ON 03/01/2007. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007, RATIO: 7.2, LAB: 9.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060638

    Patients

    Seq Age Sex Outcome Treatment
    1 *