BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2971545 · Received February 1, 2013

    Report

    Report Number
    2027969-2013-00109
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB FOR PATIENT #2. COMPLAINT SUMMARY: DATE: (B)(6) 2013, PATIENT: #2, INRATIO: 2.8, LAB: 5.0. CALLER DID NOT KNOW THE TIME BETWEEN TESTS. PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45334 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 K291555

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN