BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1813131 · Received August 18, 2010

    Report

    Report Number
    2027969-2010-01229
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" (B)(6) 2010 INR = 1.8; (B)(6) 2010 INR = 1.0, 3.1. NURSE DID NOT REALIZE YOU CANNOT MOVE THE METER; IT MUST REMAIN ON STABLE SURFACE. PT HAS END-STAGE CONGENITAL DYSERYTHROPOIETIC ANEMIA (CDA), HISTORY OF A FIBRILLATION, CAD WITH MULTIPLE STENTS. NOT ON HEPARIN/LOVENOX, NO ANTIBIOTICS. COUMADIN REGIMEN IS 6 MG/D 3X/WK AND 4 MG/D 4X/WK. TARGETED RANGE IS "GREATER THAN 2.0." THE METER AND STRIPS ARE PASSED AROUND AMONG THE TRAVELING NURSES SO, CUSTOMER SUSPECTS THE STRIPS MAY HAVE BEEN COMPROMISED DUE TO HEAT. CUSTOMER WILL TRY FRESH STRIPS FROM LAB CABINET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 226219

    Patients

    Seq Age Sex Outcome Treatment
    1