BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 893004 · Received August 10, 2007

    Report

    Report Number
    2954730-2007-00363
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 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 : FIRST TEST INR = 1.5 SECOND TEST INR = 1.1 MEAN = 1.3 ; SD = 0.28; %CV = 22%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. PER INTERNAL PROTOCOL, IN-HOUSE RETAIN STRIPS 060656 WERE TESTED FOR PRECISION. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE %CV IS LESS THAN OR EQUAL TO 16%, THEN IT MEETS THE CRITERIA FOR PRECISION. IF BOTH SAMPLES PASS FOR EACH LOT THEN NO FURTHER ACTION IS REQUIRED. IF ONE LOT FAILS, THEN ADDITIONAL TESTING WILL BE PERFORMED WITH 2 MORE NORMAL DONORS. IF BOTH SAMPLES FAIL ON ANY LOT OR IF ANY LOT FAILS ADDITIONAL TESTING, THEN A REVIEW OF TRENDING DATA WILL BE PERFORMED AND A COURSE OF ACTION TAKEN. RESULT OF RETAINED STRIPS TEST ( LOT 060656) PERFORMED IN 2007 AS FOLLOWS: LOT 060656 PT. #1: NORMAL 1.0, NORMAL 1.2, MEAN 1.2, SD 1.1, %CV 0.14%. PT #2: NORMAL 1.0, NORMAL 1.0, MEAN 1.0, SD 0.0, %CV 0.0%. BASED ON THE ABOVE TEST RESULTS, RETAINED STRIPS LOT 060656 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 1.5, SECOND TEST INR = 1.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 060656

    Patients

    Seq Age Sex Outcome Treatment
    1 YR