BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4121365 · Received September 19, 2014

    Report

    Report Number
    2027969-2014-00861
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT INRATIO VALUES; 1 HOUR BETWEEN INRATIO TESTS; 1 1/2 HOURS BETWEEN SECOND INRATIO TEST AND LAB. ALL TESTS WITHIN 2 2/12 HOURS. PATIENT'S THERAPEUTIC RANGE 1.5 -2.5. VITAMIN K ADMINISTERED AND WARFARIN HELD BASED ON LAB RESULT ON (B)(6). NO HOSPITALIZATION OCCURRED. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583476 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 340805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PERCOCET: NO DOSE PROVIDED.| MAGNESIUM OXIDE: NO DOSE PROVIDED.| WARFARIN: 2.5MG X3/WEEK, 5MG X4/WEEK| CHEMOTHERAPY: 2 WEEKS PRIOR, NO DOSE AVAILABLE.| INRATIO MONITOR: SERIAL # (B)(4)