BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1853434 · Received September 28, 2010

    Report

    Report Number
    2027969-2010-01592
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 4.3, 4.5, LAB: 2.5. PATIENT HAS BEEN ON COUMADIN FOR ABOUT 5 WEEKS. HE WAS OFF LOVENOX 3 WEEKS AGO. HIS TARGET RANGE 2.5 - 3.5. HIS RECENT READINGS: 09/01: 2.3, 09/02: 2.0, (B)(6): LAB 2.5, IMMEDIATELY AFTER METER 4.3, REPEAT ON DIFFERENT FINGER 4.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232886

    Patients

    Seq Age Sex Outcome Treatment
    1