BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2035827 · Received March 1, 2011

    Report

    Report Number
    2027969-2011-00422
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. ADDITIONAL OTHER NUMBER: (B)(4).

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 1.0, 1.4, 1.5. NURSE TESTED HERSELF (A NON-COUMADIN USER) USING THREE DIFFERENT STRIP LOTS AND TWO DIFFERENT METERS. NURSE TESTED HERSELF USING METER #2 AND NEW STRIP LOT 243103; GOT 1.0. TESTED AGAIN ON SAME FINGER USING METER #1 AND ORIGINAL STRIP LOT 232886; GOT 1.5. GOT NEW STRIPS (LOT 232232) LATER IN THE DAY AND TESTED AGAIN ON METER #1 WITH DIFFERENT FINGER; GOT 1.4. NURSE HAS HAD A COLD AND IS TAKING ASPIRIN, BUT IS NOT ON COUMADIN OR OTHER ANTICOAGULANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232232

    Patients

    Seq Age Sex Outcome Treatment
    1