BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2852692 · Received November 14, 2012

    Report

    Report Number
    2027969-2012-01610
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012; INRATIO: 1.2; RE-TEST: 1.9; LAB: 2.5. THE RE-TEST RESULT WAS OBTAINED 1 HOUR AFTER THE INITIAL INRATIO RESULT. THE LAB DRAW WAS DONE IMMEDIATELY AFTER THE RE-TEST RESULT WAS OBTAINED. THE CUSTOMER USED A RED COLLECTION TUBE AND APPLIED THE BLOOD TO THE STRIP WITH A CLEAR PLASTIC 1ML TRANSFER PIPET. THERAPEUTIC RANGE: 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 291558

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDICATION: COUMADIN