BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2903382 · Received December 14, 2012

    Report

    Report Number
    2027969-2012-01710
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO THE LAB. RESULTS AS FOLLOW: DATE (B)(6) 2012, INRATIO 0.9, LAB 1.6. PT'S THERAPEUTIC RANGE IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LOVENOX