BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1760060 · Received July 7, 2010

    Report

    Report Number
    2027969-2010-00907
    Event Type
    Malfunction
    Date Received
    July 7, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER WAS PERFORMING VALIDATION TESTS ON TWO INRATIO METERS SIDE-BY-SIDE ON 20 PTS. MOST RESULTS MATCHED VERY WELL ON BOTH METERS WHILE OTHERS (ABOUT 4 TOTAL) WERE DISCREPANT. TWO PT RESULTS (INCLUDING ONE DISCREPANT) WERE IN THE 5-6 RANGE THAT SHOULD NOT BE USED FOR CORRELATION. THREE PT SAMPLES WERE SENT TO THE LAB FOR COMPARISON; TWO OF THESE WERE IN THE 5-6 RANGE AND ONE IS ONE OF THE DISCREPANT RESULTS LISTED BELOW. THREE DISCREPANT PT EXAMPLES: 3.2 AND 2.9 ON METER 1 VS. 4.0 AND 1.9 ON METER 2 (NES ERROR, TOO); 1.4 AND 2.7 ON METER 1 VS. 2.6 AND 2.0 ON METER 2; 3.2 AND 3.1 ON METER 1 VS. 1.6 AND 1.7 ON METER 2 -- LAB 2.8. METER #1 IS (B)(4) AND METER #2 IS (B)(4). TWO LOTS OF STRIPS WERE USED ON BOTH METERS. ONE STRIP LOT, 229443, IS INCLUDED IN THIS MEDWATCH REPORT. THE OTHER STRIP LOT WILL BE COVERED IN A SEPARATE REPORT. NO INFO READILY AVAILABLE ABOUT PT HISTORY OR DIET; PTS WERE ON LOVENOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 228136

    Patients

    Seq Age Sex Outcome Treatment
    1