BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1864574 · Received October 5, 2010

    Report

    Report Number
    2027969-2010-01660
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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: LAST WEEK, INRATIO: 1.2, RE-TEST: 5.9, LAB: 2.8 ( SAME DAY). DATE: (B)(6) 2010, INRATIO: 5.9, RE-TEST: 4.8, LAB: 3.3. RE-TEST ON (B)(6) 2010, AND LAB DRAW WERE PERFORMED AT THE SAME TIME. CALLER SUSPECTS STRIPS MAY HAVE BEEN COMPROMISED BY HEAT WHEN BOXES WERE LEFT OUTSIDE ABOUT A MONTH AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1