BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2231299 · Received July 25, 2011

    Report

    Report Number
    2027969-2011-01638
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 1.X, RETEST INRATIO: 7.X. PT'S TARGET RANGE IS 2.0 - 2.5. RESULTS DONE WITHIN 10 MINUTES OF EACH OTHER. NURSE DID NOT KNOW OF THE DECIMAL PLACE VALUES FOR THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 251113

    Patients

    Seq Age Sex Outcome Treatment
    1