BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2213827 · Received August 4, 2011

    Report

    Report Number
    2027969-2011-01734
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 4, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 6.4. ON (B)(6) 2011: 6.6, 7.5, 5.4. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR. ON (B)(6) 2011, PT DECIDED TO STOP TAKING COUMADIN DUE TO 6.4 INR RESULT WITHOUT INSTRUCTIONS FROM PHYSICIAN. PT ALSO STARTED EATING MORE GREENS. ON (B)(6) 2011, PT WENT TO DOCTOR'S OFFICE AND TESTED ON AN UNK POINT-OF-CARE METER. THE RESULT WAS TOO HIGH TO GIVE A VALUE AND THE PT WAS RESCHEDULED FOR CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1 NI