BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1893926 · Received November 1, 2010

    Report

    Report Number
    2027969-2010-01847
    Event Type
    Other
    Date Received
    November 1, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 1, 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
    WA, US
    Reporter Occupation
    OTHER

    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) 2010, INRATIO: 2.7, LAB: 6.9. FINGERSTICK WAS DONE AT 9:30 AM ON FRIDAY, AND GOT INR OF 2.7. PT WENT TO DOCTOR'S LATER THAT DAY AND DID BLOOD WORK (SOMETIME BEFORE NOON, BUT PROBABLY OVER AN HOUR AFTER FINGERSTICK) AND GOT INR OF 6.9. PT WAS COUGHING BLOOD AND ADMITTED TO HOSPITAL WITH HEMOPTYSIS. REVIEWED PT HISTORY. PT HAD BEEN ON COUMADIN FOR ALONG TIME AND INR WAS FAIRLY STABLE. DOCTOR MADE MINOR ADJUSTMENTS TO DOSAGE NEARLY EVERY WEEK (3 DAYS AT 2 MG AND 4 DAYS AT 1 MG VS 2 MG 5 DAYS AND 1 MG 2 DAYS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O