BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1903037 · Received November 12, 2010

    Report

    Report Number
    2027969-2010-01953
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: (B)(6) 2010; INRATIO: 6.9, 6.1. DATE: (B)(6) 2010, LAB: 1.9. NEW USER. TARGET RANGE 2.5-3.5. PATIENT FOLLOW UP ON (B)(6) 2010: RECEIVED NEW METER; CORRELATES WELL. INRATIO METER 2.2, LAB 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1