BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2221260 · Received August 17, 2011

    Report

    Report Number
    2027969-2011-01847
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 17, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT TESTED A NEW LOT OF STRIPS AND GOT A RESULT OF 3.3. HER THERAPEUTIC RANGE IS 2.6-3.5 AND THE DOCTOR PREFERS RESULTS TO BE IN LOW 3'S. PT MENTIONED THAT HER FINGER CONTINUED TO BLEED DESPITE PUTTING PRESSURE ON IT; THIS IS NOT NORMAL FOR HER. TECH SVC DISCUSSED POSSIBLE INTERFERENCE FROM ANEMIA AND LIVER TROUBLE. PT DID NOT KNOW HER HEMATOCRIT. TECH SVC ADVISED DISCUSSING WITH DOCTOR TO SEE IF METER WOULD BE APPROPRIATE FOR HER TO CONTINUE USING DUE TO ANEMIA. TECH SVC ADVISED PT TO CONTACT DOCTOR TO GET CONFIRMATORY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 254609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other