BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    MDR report key: 3853864 · Received April 18, 2014

    Report

    Report Number
    2027969-2014-00352
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INRATIO2 PT/INR PROFESSIONAL TEST STRIP LOT NUMBER 335553 REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER 2027969-2014-00353. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 INR RESULTS IN COMPARISON TO THE LABORATORY INR RESULT AND ALTERNATE INRATIO2 INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014: INRATIO2 MONITOR SN (B)(4), STRIP LOT 331922, INR= 7.0; INRATIO2 MONITOR SN (B)(4), STRIP LOT 335553, INR= 2.6; INRATIO2 MONITOR SN (B)(4), STRIP LOT 335553, INR= 1.5. LABORATORY INR: 1.5. ALL TESTING WAS PERFORMED WITHIN LESS THAN A TWO (2) HOUR TIME FRAME. THERAPEUTIC RANGE WAS NOT PROVIDED FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238702 INRATIO2 PT/INR PROFESSIONAL TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 331922

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR INRATIO2 MONITOR: SN (B)(4)| INRATIO2 STRIP: LOT 335553| INRATIO2 MONITOR: SN (B)(4)