BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2222050 · Received August 17, 2011

    Report

    Report Number
    2027969-2011-01846
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER TECHNICAL SERVICES REP, PT WAS ON LOVENOX. LOVENOX IS A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." UNABLE TO PERFORM RETAINED STRIP TEST DUE TO UNK STRIP LOT NUMBER ON THE EVENT DETAILS. NO FURTHER INVESTIGATION IS REQUIRED. TREND ANALYSIS IS NOT REQUIRED AT THIS TIME - NO STRIP LOT INFO. THIS ISSUE WILL BE SUBJECT TO FUTURE TRACKING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER AND THE LAB: DATE: (B)(6) 2011; INRATIO: 1.7; LAB: 3.6. PT'S TARGET THERAPEUTIC RANGE IS 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 NG

    Patients

    Seq Age Sex Outcome Treatment
    1