BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 887469 · Received July 27, 2007

    Report

    Report Number
    2954730-2007-00344
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 24, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    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 COMPLAINT WAS FILED: DATE 2007, INRATIO 1.8, LAB 4.2, MEAN 3.0, CONFIDENCE LIMITS: 1.8 - 4.2. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE FURTHER TESTING IS NOT REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060102: FIRST TEST INR = 1.8, SECOND TEST INR = 3.2, MEAN = 2.5; SD = 0.99; %CV = 39.6%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. PLEASE NOTE THAT LOT# 060102 EXPIRED ON 5/31/2007. PRODUCT WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE 2007, INRATIO 1.8, LAB 4.2. CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.8, SECOND TEST INR = 3.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 060102

    Patients

    Seq Age Sex Outcome Treatment
    1 YR