BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1942369 · Received December 23, 2010

    Report

    Report Number
    2027969-2010-02274
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, (B)(4) : INRATIO: >7.5, (B)(4) : RE-TEST: 1.7, LAB: 2.34. CUSTOMER COMPLETED SELF TEST (NON-COUMADIN USER) ON METER THAT GAVE >7.5 RESULT, AND IT GAVE TWO UNK ERROR MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235738

    Patients

    Seq Age Sex Outcome Treatment
    1