BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3013047 · Received March 1, 2013

    Report

    Report Number
    2027969-2013-00178
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER ALLEGES PRECISION LOW INRATIO READING. INRATIO 4.5, LAB 7.0, TIME BETWEEN TESTS 1 HOUR. PT'S THERAPEUTIC RANGE 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90182 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100139 299629

    Patients

    Seq Age Sex Outcome Treatment
    1