BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2883038 · Received December 18, 2012

    Report

    Report Number
    2027969-2012-01720
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS (USING TWO STRIPS OF THE SAME LOT) AND THE LABORATORY RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 0.9 AND 0.9, LABORATORY INR: 1.5. THE TIME BETWEEN TESTING WAS A FEW MINUTES APART. THERAPEUTIC RANGE 2.0-3.0 FOR PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 293081

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| ALBUTEROL| LASIX| HYDROCODONE| METOPROLOL| PREDNISONE