BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2132172 · Received June 3, 2011

    Report

    Report Number
    2027969-2011-01226
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 3, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER. PT'S TARGET THERAPEUTIC RANGE IS 2.0 - 3.0. PT HAD A NOSEBLEED WHILE ON THE PHONE WITH TECHNICAL SVS REP. PT JUST RECENTLY STARTED TESTING AGAIN. PT DID NOT HAVE SUPPLIES FOR A MONTH AND A HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other