BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4002159 · Received June 9, 2014

    Report

    Report Number
    2027969-2014-00561
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INRATIO PT/INR TEST STRIPS LOT #339256 REFERENCE IS BEING REPORTED UNDER A SEPARATE MFR REPORT NUMBER 2027969-2014-00559. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR: 5.0 (LOT #339256) AND 2.9 (LOT #340805). THE TIME BETWEEN TESTING WAS FIVE (5) MINUTES. THERAPEUTIC RANGE 2.0-3.0 FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336157 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 340805

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO PT/INR TEST STRIPS LOT #339256| VITAMIN D| WARFARIN 2.5MG| INRATIO MONITOR SN: UNK| VITAMIN B-12| DIGOXIN