BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1867133 · Received October 8, 2010

    Report

    Report Number
    2027969-2010-01688
    Event Type
    Other
    Date Received
    October 8, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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". BRUISING OBSERVED WHEN PT WENT TO DOCTOR. PT WAS CALLED LATER AND DOCTOR REQUESTED HE GO TO THE ED; (FINDINGS: BURSA GLAND SWOLLEN). PHYSICIAN ADVISED PT TO STOP COUMADIN FOR 2 NIGHTS. THERAPEUTIC RANGE: 2-3 (NO ISSUES BEFORE IN OBTAINING RESULTS WITHIN RANGE). ON COUMADIN FOR YEARS AND LAST DOSE ANTIBIOTICS APPROX 1 WEEK AGO (LAST DOSE WAS (B)(6) 2010). PT REPORTED ON (B)(6) 2010 THAT HE HAS BEEN ON ANTIBIOTICS, LAST DOSE WAS LAST NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 232167

    Patients

    Seq Age Sex Outcome Treatment
    1 Other