BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 790965 · Received November 22, 2006

    Report

    Report Number
    2954730-2006-00575
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    November 6, 2006
    Report Date
    November 6, 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: FIRST TEST INR = 1.0, SECOND TEST INR = 1.6, MEAN = 1.3; SD = 0.42; %CV = 32%. THE % CV IS GREATER 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. PER INTERNAL PROTOCOL, IN-HOUSE RETAIN STRIPS 060398 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 1 LOT FAILS, THE ADD'L TESTING WILL BE PERFORMED WITH 2 MORE NORMAL DONORS. IF BOTH SAMPLES FAIL ON ANY LOT OR IF ANY LOT FAILS ADD'L TESTING, THEN A REVIEW OF TRENDING DATA WILL BE PERFORMED AND A COURSE OF ACTION TAKEN. RESULT OF RETAINED STRIPS TEST (LOT 060398) PERFORMED. BASED ON THE ABOVE TEST RESULTS, RETAINED STRIPS LOT 060395 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR=1.0, SECOND TEST INR=1.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060398

    Patients

    Seq Age Sex Outcome Treatment
    1 *