BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1936048 · Received December 15, 2010

    Report

    Report Number
    2027969-2010-02185
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 15, 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
    GA, US
    Reporter Occupation
    NURSE

    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; INR: 2.3; LAB: 7.0. RN ALSO COMPLAINED SHE WAS GETTING 7 OR >7.5 ON 8 OUT OF 15 PTS. THIS PT HAD A 2.3 INR ON THE METER AND WAS SENT TO THE LAB WHICH GOT 7.0. COUMADIN ADJUSTED ACCORDING TO LAB RESULTS. ADVERSE REACTION OCCURRED WITH PT RECEIVING BLOOD BECAUSE OF INTERNAL BLEEDING. PT WAS SENT TO ER AND THEN ADMITTED TO THE HOSPITAL. THERAPEUTIC RANGE 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239277

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O