BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2470424 · Received February 24, 2012

    Report

    Report Number
    2027969-2012-00216
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 24, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS NOT PERFORMED ON INRATIO AND REFERENCE RESULTS SINCE PT WAS ON LOVENOX THERAPY AT THE TIME OF TESTING. LOVENOX IS A MEMBER OF A CLASS OF ANTITHROMBOTIC AGENTS KNOWN AS A LOW-MOLECULAR-WEIGHT HEPARINS (LMWH). PER PRODUCT USER GUIDE - LIMITATIONS, "THIS TEST SHOULD NOT BE USED FOR PTS ON HEPARIN THERAPY." FURTHER INVESTIGATION COULD NOT BE PERFORMED SINCE NO STRIP LOT INFO WAS PROVIDED BY THE CUSTOMER. THIS COMPLAINT ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER (NURSE) ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 2.1, LAB: 7.5. DATE: (B)(6) 2012, INRATIO: 2.1, LAB: 6.2. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR. PT WAS ADMITTED TO THE HOSP DUE TO BLOOD IN THE STOOL. AT THE TIME OF COMPLAINT, PT WAS ON LOVENOX FOR THE LAST WEEK DUE TO COLONOSCOPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other