BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2231277 · Received July 25, 2011

    Report

    Report Number
    2027969-2011-01629
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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) 2011, INRATIO2: 5.4, LAB: 3.4; (B)(6) 2011, 7.4, 5.1. PT'S THERAPEUTIC RANGE: 3.0 - 3.5 INR. PT'S COUMADIN WAS RECENTLY ADJUSTED BASED ON LAB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1 NI