BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1800642 · Received August 4, 2010

    Report

    Report Number
    2027969-2010-01121
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    June 22, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. ADD'L LOT #S: 233029, 227886.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR: 5.5 (LOT #228759); 0.7 (LOT #233029); 1.1 (LOT #227886). ACCORDING TO THE DISTRIBUTOR, A FEW MEASUREMENTS WERE HIGHER THAN 7.5 BUT THE LAB TEST RESULTS WERE BETWEEN 2 AND 3 INR. THESE WERE ALL MEASURED WITH LOT #228759.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 228759

    Patients

    Seq Age Sex Outcome Treatment
    1 NI