BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1853438 · Received September 28, 2010

    Report

    Report Number
    2027969-2010-01590
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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: 1.9 - 2.1. DATE: (B)(6) 2010, INRATIO: 1.6, LAB: 6.2, DOCTORS POC: 9.0. DATE: (B)(6) 2010, INRATIO: QC ERROR. LAB: 2.4. FOUR HOUR GAP BETWEEN INRATIO AND LAB TESTING, AND ALSO LAB/DOCTORS POC RESULT ON (B)(6) 2010. PATIENT HAD BEEN ON ANTIBIOTICS ON (B)(6) 2010. THERAPEUTIC RANGE: 1.6 - 2.2. NURSE REPORTS NO BRUISING OR BLEEDING, AND INCISION FROM SURGERY IS HEALING WELL. NURSE USES THE SECOND DROP OF BLOOD, AND ALSO STORING STRIPS IN A HOT CAR. ON (B)(6) 2010, PATIENT HAS SINCE DISCONTINUED COUMADIN THERAPY AND IS NO LONGER ABLE TO DO COMPARISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1