BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4014162 · Received July 1, 2014

    Report

    Report Number
    2027969-2014-00629
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT LOW INRATIO VALUES. ON (B)(6) 2014, INRATIO: 1.4, LAB: 2.1, 45 MINUTES BETWEEN TESTINGS. ON (B)(6) 2014, INRATIO: 1.9, LAB: 2.7, 45 MINUTES BETWEEN TESTINGS. PATIENT'S THERAPEUTIC RANGE 1.8 - 2.5. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381944 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN: 2MG A DAY, THURSDAY 4 MG| INRATIO MONITOR SERIAL # (B)(4)