BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2190063 · Received June 29, 2011

    Report

    Report Number
    2027969-2011-01431
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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, INRATIO: 2.5, LAB: 2.0. DATE: (B)(6) 2011, INRATIO: 4.1, LAB: 2.6. PT'S THERAPEUTIC RANGE: 2.5-3.5. CUSTOMER STATES THAT METER HAS PREVIOUSLY CORRELATED WELL WITH THE LAB. ADVISED CUSTOMER THAT METER HAS NOT BEEN VALIDATED FOR USE ON MINORS (B)(6).

    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