BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1586250 · Received January 6, 2010

    Report

    Report Number
    2027969-2010-00014
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 6, 2010
    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

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.5; REFERENCE: 3.4; MEAN: 2.95; CONFIDENCE LIMITS: 1.8-4.2. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. METER AND STRIPS WERE NOT EXPECTED TO BE RETURNED. TRENDING AND TRACKING WILL BE PERFORMED IN REVIEW OF STRIP LOT #220392. TOTAL NUMBER OF DISCREPANT COMPLAINTS, INCLUDING THIS EVENT, IS FOUR. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULT COMPARED WITH THE DOCTOR'S POC METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2009; INRATIO: 2.5; DOCTOR'S POC: 3.4.

    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