BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1970405 · Received January 18, 2011

    Report

    Report Number
    2027969-2011-00116
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, LAB: 1.85, (B)(6) 2010, DOCTOR'S POC METER: 2.1. (B)(6) 2010, INRATIO: 1.4. CALLER ALSO REPORTED GETTING A QC2H ERROR ON (B)(6) 2010. PATIENT WENT TO DOCTOR'S ON THURSDAY LAST WEEK (B)(6) AND GOT SAMPLE OF PRADAXA. SHE TOOK IT FOR A COUPLE OF DAYS AND DISCONTINUED IT ON SUNDAY (B)(6). WAS STILL TAKING WARFARIN THE WHOLE TIME. ALSO STARTED BACTRIM YESTERDAY (B)(6) AFTER BEING OFF OF IT FOR 2-3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243699

    Patients

    Seq Age Sex Outcome Treatment
    1