BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2073909 · Received April 13, 2011

    Report

    Report Number
    2027969-2011-00891
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 21, 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.8 (STRIP LOT #234523), 3.8 (STRIP LOT #241836), 3.4 (STRIP LOT #241836). CALLER ALSO REPORTED DISCREPANT RESULTS COMPARED TO A LAB POINT-OF-CARE (POC) METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.2, LAB POC: 2.8. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 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