BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2201054 · Received July 1, 2011

    Report

    Report Number
    2027969-2011-01451
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 7.5, LAB DRAW: 4.0, LAB METER: 4.0, >7.5. THE PT RECEIVED A .7.5 ON HIS METER IN THE DR OFFICE AND WAS SENT TO THE ER FOR LAB TESTS WHERE HE RECEIVED A 4.0 AND THAT WAS WHERE THEY WANT HIM AT. HE TESTED ON THE LAB METER AND GOT A 4.0 AND THEN SECONDS LATER RETESTED ON THE SAME METER AND GOT A >7.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251115

    Patients

    Seq Age Sex Outcome Treatment
    1