BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PROFESSIONAL PT/INR TEST STRIPS

    MDR report key: 4073789 · Received June 23, 2014

    Report

    Report Number
    2027969-2014-00601
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULT WHILE PERFORMING A CORRELATION STUDY. RESULTS AS FOLLOWS: FILE # 290290. INRATIO: 2.6. LAB 1: 1.82. LAB 2: 1.57. FILE # 442390. DIAGNOSIS: CEREBRAL HGE. INRATIO: 3.0. LAB 1: 1.2. FILE # 319955. DIAGNOSIS: A.V.R. INRATIO: 5. LAB 1: 2.89. NO OTHER PT INFO WAS PROVIDED. CORRELATION STUDY WAS PERFORMED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365930 INRATIO2 PROFESSIONAL PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS099008EU K318843

    Patients

    Seq Age Sex Outcome Treatment
    1 LAB MACHINES: ACL-TOP 500 CTS 12072279| STAGO STR REVOLUTION