BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRATIO

    MDR report key: 2802561 · Received October 19, 2012

    Report

    Report Number
    2027969-2012-01538
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE (B)(6) 2012: INRATIO READING 1: 2.0 LOT: 279124; INRATIO READING 2: 4.5 LOT: 279124; INRATIO READING 3: 4.6 LOT: 279124; INRATIO READING 4: 4.4 LOT: 279124; INRATIO READING 5: 4.9 LOT: 289284. TIME BETWEEN TESTING WAS 5 MINUTES. PT'S THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 279124

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN