BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2010237 · Received February 11, 2011

    Report

    Report Number
    2027969-2011-00300
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: (B)(4). DATE: (B)(6) 2011, INRATIO(A): 1.7, LAB: -. (B)(6) 2011, -, 4.4. ON (B)(6) 2011, A CORRELATION WAS PERFORMED WITH INRATIO (A) AND THE LAB WITH THE FOLLOWING RESULTS: (B)(4) INRATIO(A): 3.0, LAB: 4.2. ON (B)(6) 2011, ANOTHER CORRELATION WAS PERFORMED WITH TWO INRATIO METERS WITH THE FOLLOWING RESULTS: (B)(4) INRATIO (A): 4.0, (B)(4) INRATIO(B): 3.5, LAB: 7.7. THE SAME STRIP LOT WAS USED FOR ALL TESTING. TESTING ON (B)(6) 2011 USED THE SAME FINGER STICK; WITH THE FIRST DROP ON METER A AND THE SECOND DROP ON METER B. NURSE REPORTS THERE BEING GOOD AGREEMENT BETWEEN THE METERS AND OTHER PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1