BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 916266 · Received March 23, 2007

    Report

    Report Number
    2954730-2007-00140
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    March 18, 2007
    Report Date
    March 23, 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 LOT 060452: FIRST TEST INR = >7.5; SECOND TEST INR = 6.7; MEAN = UNABLE TO BE DETERMINED; SD = UNABLE TO BE DETERMINED; CV = UNABLE TO BE DETERMINED %. THE %CV CANNOT BE DETERMINED BECAUSE THE FIRST READING WAS >7.5. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. PER INTERNAL PROTOCOL PR 103, IN-HOUSE RETAIN STRIPS 060452 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 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 060452) PERFORMED IN 2006 AS FOLLOWS: SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, PER PR 0103, RETAINED STRIPS LOT 060452 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO: RESULTS AS FOLLOWS: FIRST TEST INR = >7.5. SECOND TEST INR = 6.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060452

    Patients

    Seq Age Sex Outcome Treatment
    1 *