BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2802577 · Received October 19, 2012

    Report

    Report Number
    2027969-2012-01537
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT LOW, METER = 2.0, LAB = 5.0, MANAGER CALLING ON BEHALF OF HOME HEALTH NURSE WHO, WHEN TESTING PATIENT ON METER RECEIVED A 2.0. PATIENT SELF TESTER WENT TO THE EMERGENCY ROOM AND RECEIVED A 5.0 INR READING. CALLER STATED THAT THE EMERGENCY ROOM VISIT WAS NOT RELATED TO THE PT'S INR READING. PT'S THERAPEUTIC RANGE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1