BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2150394 · Received June 8, 2011

    Report

    Report Number
    2027969-2011-01277
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6)2011, FIRST INRATIO: 2.7. DATE: (B)(6) 2011, FIRST INRATIO: 1.3, SECOND INRATIO: 1.4, LAB: 2.1. DATE: (B)(6) 2011, FIRST INRATIO: 1.8. THIRTY (30) MINUTES BETWEEN METER AND LAB DRAW. PATIENT REPEATED THE TEST WHILE ON THE PHONE WITH TECHNICAL SUPPORT. PATIENT'S TARGET RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI