BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3060905 · Received April 10, 2013

    Report

    Report Number
    2027969-2013-00288
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ALER SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO PRECISION RESULTS COMPARED WITH LAB. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013; INRATIO: 5.7; INRATIO RE-TEST: 1.8. THERAPEUTIC RANGE: 2 - 3. TIME: 15 MINUTES BETWEEN TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150052 INRATIO PROTHROMBIN TIME TEST GJS ALER SAN DIEGO INC. 100071 297451A

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| GABAPENTIN: STARTED TAKING| PENICILLIN: LAST DOES WAS TAKEN A WEEK AGO