BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4102257 · Received August 26, 2014

    Report

    Report Number
    2027969-2014-00783
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANCY HIGH INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR: 6.0, 2.0. THE TIME BETWEEN TESTING WAS TWO HOURS. REPORTEDLY, MILKING FINGER AFTER FINGER STICK, UNABLE TO OBTAIN SUFFICIENT BLOOD SAMPLE AND TOUCHED FINGER TO SAMPLE WELL. THERAPEUTIC RANGE 2.0 - 3.0 FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518518 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 346762

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| INRATIO MONITOR: SN # (B)(4)