BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2040050 · Received March 9, 2011

    Report

    Report Number
    2027969-2011-00465
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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) 2011, INRATIO2: 3.3, LAB: 2.32. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 3.7, 4.5. HISTORICALLY, PT STAYS BETWEEN 2.2 AND 2.5 INR. HE IS A PILOT AND IF HE GETS ABOVE 3 INR MORE THAN A COUPLE OF TIMES, HE WILL NOT BE ALLOWED TO FLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI