BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2070731 · Received April 14, 2011

    Report

    Report Number
    2027969-2011-00825
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 0.8, 0.9, 1.3. CALLER ALSO REPORTED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 2.2, LAB: 1.9. DOCTOR KEPT INCREASING PT'S COUMADIN DOSE BASED ON LOW INRATIO RESULTS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 239279

    Patients

    Seq Age Sex Outcome Treatment
    1 NI