BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2072991 · Received April 22, 2011

    Report

    Report Number
    2027969-2011-00902
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLERS ALLEGED IMPRECISION WITH INRATIO METER. NOT ENOUGH SAMPLE, MULTIPLE DROPS WERE USED FROM THE SAME FINGER. PT'S THERAPEUTIC RANGE: (2 TO 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 234523

    Patients

    Seq Age Sex Outcome Treatment
    1 NI