BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2230933 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01597
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 20, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION BETWEEN INRATIO2 AND INRATIO1 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INR: >7.5 (INRATIO2), 1.8 (INRATIO1). PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR. LAST MONTH, PATIENT'S INR WAS 2.0 (TESTED ON THE INRATIO 1 METER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 247450

    Patients

    Seq Age Sex Outcome Treatment
    1 NI