BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1890653 · Received October 29, 2010

    Report

    Report Number
    2027969-2010-01835
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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, INRATIO: >7.5, LAB: 2.6. CUSTOMER REPORTED A >7.5 RESULT ON FINGERSTICK FROM ONE PT. DREW BLOOD IMMEDIATELY AND SENT TO LAB; HAD ERROR 114 USING DROP FROM SYRINGE ON METER AND LAB DRAW GAVE RESULT OF 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1