BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2101539 · Received May 20, 2011

    Report

    Report Number
    2027969-2011-01130
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: 4.0. DATE: (B)(6) 2011, INRATIO: 1.4. PATIENT'S THERAPEUTIC RANGE: 3-4 INR. PATIENT HAD A NOSE BLEED ON (B)(6) 2011. SHE IS ALREADY IN DISCUSSION WITH HER DOCTOR ABOUT HER THERAPEUTIC RANGE BEING HIGH BECAUSE SHE EXPERIENCES BLEEDING. PATIENT HELD HER COUMADIN PER PHYSICIAN'S RECOMMENDATION. PATIENT HAS BEEN FLUCTUATING SINCE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 232886

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other