BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1910828 · Received November 22, 2010

    Report

    Report Number
    2027969-2010-02019
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULT COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.3, LAB: 2.6. CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR: 4.0, 1.3. DIRECTOR OF NURSING ALSO REPORTED THAT METER RESULTS FOR EVERYONE WAS 1.3 INR, EVEN NON-COUMADIN PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 237432

    Patients

    Seq Age Sex Outcome Treatment
    1 NI