BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 968654 · Received October 6, 2006

    Report

    Report Number
    2954730-2006-00529
    Event Type
    Malfunction
    Date Received
    October 6, 2006
    Date of Event
    October 4, 2006
    Report Date
    October 4, 2006
    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 060128: FIRST TEST INR = 5.5. SECOND TEST INR = 3.0. THIRD TEST INR = 4.4, MEAN = 4.3; SD = 1.25; %CV = 29%. 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 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 060128) PERFORMED IN 2006 AS FOLLOWS: LOT 060128 PT. #1 NORMAL 0.9, NORMAL 0.9, MEAN 0.9, SD 0, %CV 0%. PT. #2 NORMAL 1.1, NORMAL 1.1, MEAN 1.1, SD 0, %CV 0%. BASED ON THE ABOVE TEST RESULTS, RETAINED STRIPS LOT 060128 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 5.5. SECOND TEST INR = 3.0. THIRD TEST INR = 4.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060128

    Patients

    Seq Age Sex Outcome Treatment
    1 *