BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 920733 · Received September 25, 2007

    Report

    Report Number
    2954730-2007-00453
    Event Type
    Malfunction
    Date Received
    September 25, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 21, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PREVISION DATA PROVIDED BY END-USER LOT 070163: FIRST TEST INR = >7.5 SECOND TEST INR = 3.5. MEAN = UNABLE TO BE DETERMINED ; SD = UNABLE TO BE DETERMINED; %CV = UNABLE TO BE DETERMINED. THE %CV CANNOT BE DETERMINED BECAUSE ONE OF THE INRATIO RESULTS WAS >7.5. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. PER INTERNAL PROTOCOL 4 RETAINED STRIP 070163 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. RESULTS OF RETAINED TEST STRIP (LOT 070163) PERFORMED IN 2007, ARE AS FOLLOWS: BASED ON THE ABOVE TEST RESULTS, THE RETAIN STRIP LOT 070163 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = >7.5 SECOND TEST INR = 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070163

    Patients

    Seq Age Sex Outcome Treatment
    1 YR