BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2844260 · Received November 8, 2012

    Report

    Report Number
    2027969-2012-01600
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 8, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGE DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 5.0, RETEST: 2.5, (NEW LOT) RETEST: 2.6. REPEAT TESTS WERE PERFORMED WITHIN 5 MINUTES OF EACH OTHER. THERAPEUTIC RANGE: 2.0-3.0. CUSTOMER STATED THERE WAS NO BRUISING OR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 291548

    Patients

    Seq Age Sex Outcome Treatment
    1