BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2132413 · Received June 13, 2011

    Report

    Report Number
    2027969-2011-01317
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: (B)(4) INRATIO: >7.5. (B)(4) INRATIO: (B)(4): >7.5. DATE: (B)(6) 2011, INRATIO: 7.3, LAB: 5.3. CUSTOMER TOOK HIS INRATIO READING 30 MINUTES PRIOR TO GOING TO LAB. TAKES 5 MG/DAY EXCEPT ON MONDAYS WHERE HE TAKES 7.5 MG. NO BRUISING OR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1