BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4213418 · Received October 23, 2014

    Report

    Report Number
    2027969-2014-00970
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 0.8 AND >7.5. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS FIVE MINUTES. REPORTEDLY, THE PATIENT IS (B)(6) YEARS OLD AND THE PATIENT'S FINGER TOUCHED THE SAMPLE WELL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674626 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 346762

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR COUMADIN| INRATIO MONITOR: SN (B)(4)