BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2801069 · Received October 17, 2012

    Report

    Report Number
    2027969-2012-01524
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    ¿CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE HOSPITAL LAB. RESULTS AS FOLLOWS:¿ DATE: (B)(6) 2012, INRATIO2: 1.6, 2.0, LAB: 3.5. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS ONE HR. PT¿S THERAPEUTIC RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 289504

    Patients

    Seq Age Sex Outcome Treatment
    1 NI