BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2150368 · Received June 8, 2011

    Report

    Report Number
    2027969-2011-01271
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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) 2011, INRATIO: 4.3, LAB: 3.4. PATIENT'S THERAPEUTIC RANGE: 2.0-3.5 INR. PATIENT HAS BEEN STABLE FOR SEVERAL YEARS AND HAS BEEN TESTING AT HOME FOR ABOUT 6 YEARS NOW, BUT HAS HAD HIGH RESULTS LATELY, WHICH PROMPTED THE LAB TEST. HE HAD ANTIBIOTICS ABOUT 6 WEEKS PRIOR TO TESTING ON (B)(6) 2011, BUT NONE SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI