BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1566530 · Received December 4, 2009

    Report

    Report Number
    2027969-2009-01138
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    November 10, 2009
    Report Date
    December 4, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON 4.7 AND 3.5 INR RESULTS BECAUSE THEY WERE OBTAINED MORE THAN 3 HOURS FROM EACH OTHER. SINCE TIME OF TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. IN REVIEW OF TECHNIQUE, TS FOUND IMPROPER USER TECHNIQUE. IT WAS INDICATED THAT USER MILKED FINGER. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. FURTHER ACTION IS NOT REQUIRED. AS OF 11/30/2009, THREE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220392. TRENDING AND TRACKING WILL BE DONE IN REVIEW OF STRIP LOT #220392. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6)2009; INRATIO: 4.7; LAB: 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 220392

    Patients

    Seq Age Sex Outcome Treatment
    1 NI