BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1978409 · Received January 27, 2011

    Report

    Report Number
    2027969-2011-00195
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 27, 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
    ID, 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: 1.8, LAB: 2.3. DATE: (B)(6) 2010, INRATIO: 2.3, LAB: 2.2. DATE: (B)(6) 2010, INRATIO: 2.0, LAB: 2.3. CALLER ALSO ALLEGED IMPRECISION WITH ANOTHER STRIP LOT #243699. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 1.9 (STRIP LOT #243699). DATE: (B)(6) 2010, INR: 1.8 (STRIP LOT #241836). DATE: (B)(6) 2010, INR: 2.2 (STRIP LOT #243699). DATE: (B)(6) 2010, INR: 2.3 (STRIP LOT #241836). DATE: (B)(6) 2010, INR: 1.8 (STRIP LOT #243699). DATE: (B)(6) 2010, INR: 2.0 (STRIP LOT #241836). PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI