BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3862871 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00137
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. THE INRATIO 2 PT/INR PRO MONITOR SN (B)(4) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER 2027969-2014-00138.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT CORRELATION INRATIO2 INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6_ 2014, INRATIO INR: 1.0 AND 3.7. TWO (2) DIFFERENT INRATIO2 MONITORS, SN (B)(4) AND SN (B)(4), WERE USED WITH THE SAME STRIP LOT. HOWEVER, THE CUSTOMER WAS UNABLE TO DETERMINE WHICH MONITOR PRODUCED WHICH RESULT. THE TIME BETWEEN TESTING WAS LESS THAN TEN (10) MINUTES. THERAPEUTIC RANGE 2.0 - 3.0 FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104315 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 99008G2 332842

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| INRATIO 2 PT/INR PRO MONITOR SN (B)(4)| INRATIO 2 PT/INR PRO MONITOR SN (B)(4)