BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1954382 · Received December 14, 2010

    Report

    Report Number
    2027969-2010-02168
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. CALLER IS A PROFESSOR WHO RAN HIS OWN CORRELATION STUDY. AFTER RECEIVING ORENCIA INFUSIONS FOR RA, HE NOTICED HIGH (+15%) DISCREPANCIES. PT CALIBRATES HIS READINGS MATHEMATICALLY FOR PHYSICIAN DOSAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1