BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2060690 · Received April 8, 2011

    Report

    Report Number
    2027969-2011-00750
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 7.0, 5.8. INITIAL INRATIO=7.0. REPEAT USING A DIFFERENT LOT OF STRIPS (NO LOT INFO) INRATIO=5.8. CUSTOMER DID USE A NEW FINGER STICK, BUT HADN'T CHANGED THE STRIP CODE. 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 247452

    Patients

    Seq Age Sex Outcome Treatment
    1