BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1833438 · Received September 8, 2010

    Report

    Report Number
    2027969-2010-01375
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: 2.8. FIRST DRAW WAS UNABLE TO HAVE ENOUGH SAMPLE FROM FINGERSTICK, BUT SECOND RESULTED IN ENOUGH SAMPLE. LAB TEST WAS DRAWN WITHIN 1 HOUR OF FINGERSTICK. PATIENT DID NOT HAVE ANY ADVERSE AFFECTS NOTED.

    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