BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3111862 · Received May 7, 2013

    Report

    Report Number
    2027969-2013-00377
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, FIRST TEST: 0.9, SECOND TEST: 2.0. LESS THAN 5 MINUTES BETWEEN TESTS. THERAPEUTIC RANGE: UNKNOWN. NURSE REPORTS THAT FOR THE FIRST TEST THEY HAD DIFFICULTY OBTAINING THE SAMPLE, WHICH CAUSED THEM TO MILK THE FINGER, TAKING LONGER THAN 15 SECONDS TO APPLY THE SAMPLE, AND APPLY MULTIPLE DROPS. ADDITIONALLY ON THE FIRST TEST THEY USED A DIABETIC LANCET 30G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199964 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 294978

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 2.5MG/DAY