BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1757490 · Received July 2, 2010

    Report

    Report Number
    2027969-2010-00895
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 2, 2010
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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, INRATIO: 1.2, DOCTOR'S OFFICE: 2.0. PATIENT HAD SOME DIFFICULTY GETTING SUFFICIENT BLOOD FOR TESTING. FIRST RECEIVED AN ERROR (NES) MESSAGE BEFORE GETTING THE 1.2 INR READING. PATIENT NOT HOSPITALIZED, NO CANCER/DIALYSIS, NO ANTIBIOTICS, NO OTHER MEDICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1