BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1913751 · Received November 23, 2010

    Report

    Report Number
    2027969-2010-02041
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2010, INRATIO: 5.0, LAB: 2.5 (DRAWN WITHIN 20 MINS). DATE: (B)(6) 2010, INRATO: 2.5, LAB: 2.1 (DRAWN WITHIN 30 MINS).

    Additional Manufacturer Narrative · 2

    INVESTIGATION PENDING.

    Description of Event or Problem · 2

    PATIENT SELF TESTER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2010, INRATIO: 4.1, LAB: 3.1 (DRAWN WITHIN 30 MINS). PATIENT HAD TAKEN TYLENOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 225434

    Patients

    Seq Age Sex Outcome Treatment
    1
    2