BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 810068 · Received December 28, 2006

    Report

    Report Number
    2954730-2006-00614
    Event Type
    Malfunction
    Date Received
    December 28, 2006
    Date of Event
    November 28, 2006
    Report Date
    December 26, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 050816: FIRST TEST INR = 1.4, SECOND TEST INR = 5.3, THIRD TEST = 5.0, MEAN = 3.90; SD = 2.17; %CV = 55.6%. THE %CV IS LESS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. PRODUCT WILL BE TESTED. PER INTERNAL PROTOCOL, IN-HOUSE RETAIN STRIPS 050816 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 050816) PERFORMED ON 09/25/2006 AS FOLLOWS: LOT 050816 PT #1: NORMAL 1.0, PT #2: NORMAL 0.9; PT #1: NORMAL 1.0, PT #2: NORMAL 0.9; PT #1: MEAN 1.0, PT #2: MEAN 0.9; PT #1: SD 0.0, PT #2: SD 0.0. BASED ON THE ABOVE TEST RESULTS, RETAINED STRIPS LOT 050816 MEETS THE CRITERIA FOR STRIPS PRECISION. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060037: FIRST TEST INR = 2.5, SECOND TEST INR = 2.5. MEAN = 2.5 SD = 0.0; %CV = 0.0%. 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.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: INRATIO PRECISION DATA PROVIDED BY END-USER LOT 050816: FIRST TEST INR = 1.4, SECOND TEST INR = 5.3, THIRD TEST = 5.0. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060037: FIRST TEST INR = 2.5, SECOND TEST INR = 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050816

    Patients

    Seq Age Sex Outcome Treatment
    1 *