BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1964100 · Received January 10, 2011

    Report

    Report Number
    2027969-2011-00061
    Event Type
    Other
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. RECENT OFLOXIN INTAKE ((B)(6) 2010 TO (B)(6) 2010) FOR YEAST INFECTION. ON (B)(6) 2010, METER RESULT 1.5 - COUMADIN INCREASED TO 4MG. ON (B)(6) 2010, LAB DRAW (VENOUS) RESULT 2.6. ON (B)(6) 2010, CUSTOMER STATED COLLEAGUE OBTAINED "HIGH" ON DISPLAY (CUSTOMER KNOWS METER READS UP TO 7.5 AND BELIEVES IT WAS A QC ERROR AGAIN NOT A HIGH INR RESULT). COUMADIN WAS STOPPED DUE TO THE "HIGH" RESULT REPORTED AND PT WAS GIVEN 1 DOSE OF 10MG VITAMIN K. ON (B)(6) 2010, LAB (VENOUS) DRAW RESULTED 2.6, COUMADIN STILL NOT RESUMED. SELF-TEST WHILE ON PHONE WITH TSS (ANOTHER COLLEAGUE): 1.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 NONE GJS ALERE SAN DIEGO, INC. 100139 237433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other