BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2217296 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01538
    Event Type
    Other
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2011; INRATIO: 4.0, 3.9; LAB: 2.7. ON (B)(6) 2011. PT TESTED 4.0 ON METER, REPEATED ON A DIFFERENT FINGER WITH A 3.9 RESULT; MINUTES LATER, VENOUS DRAW WAS TAKEN AND SET TO LAB. PT'S TARGET RANGE 2-3. BEFORE LAB RESULTS (2.7) CAME BACK THE NEXT DAY, DOCTOR TOLD PT TO HOLD COUMADIN DOSE BASED ON METER READING. CALLER ALSO MENTIONED THAT ANOTHER PT HAD AN INR OF 3.5 WHEN HER INR USUALLY RUNS BETWEEN 2.1-2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 243933

    Patients

    Seq Age Sex Outcome Treatment
    1 Other