BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2820282 · Received October 31, 2012

    Report

    Report Number
    2027969-2012-01580
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2012, INRATIO2: 4.6, ERROR, 6.1; LAB: >10. THERAPEUTIC RANGE: 2.0-3.0. NO KNOWN MEDICAL CONDITIONS THAT WOULD INTERFERE WITH TEST. PT WAS HOSPITALIZED THE NEXT DAY DUE TO EVERYTHING GOING ON WITH HER INR BEING OUT OF RANGE. NOT SOLELY DUE TO INRATIO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization COUMADIN| TYLENOL #3