BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2801087 · Received October 17, 2012

    Report

    Report Number
    2027969-2012-01528
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER ALLEGES PRECISION ISSUES. CUSTOMER REPORTING IMPRECISION WHEN COMPARING TWO RESULTS USING THE SAME FINGER STICK. IMPRECISION 10/12: INRATIO INITIAL = 5.0, REPEAT = 3.7. TIME BETWEEN TESTING (2 MIN) SAME FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 289242

    Patients

    Seq Age Sex Outcome Treatment
    1