BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2493307 · Received March 12, 2012

    Report

    Report Number
    2027969-2012-00319
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 12, 2012
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2012, INRATIO: 1, LAB: 1.7. METER AND LAB RESULTS WERE DONE MINUTES APART. PT'S TARGET THERAPEUTIC RANGE IS 2 - 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100139 264481

    Patients

    Seq Age Sex Outcome Treatment
    1