BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1735082 · Received June 3, 2010

    Report

    Report Number
    2027969-2010-00705
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: (LOT# 233421) - DATE: (B)(6)2010, INRATIO: 4.6, 4.3; LAB: 3.8. (LOT# 221728) - DATE: (B)(6)2010, INRATIO: 4.0. ABOUT 1 HOUR BETWEEN METER TEST AND LAB DRAW. CUSTOMER PERFORMED A RE-TEST WHILE ON THE PHONE WITH TECHNICAL SERVICE (4.3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 233421

    Patients

    Seq Age Sex Outcome Treatment
    1