BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3896505 · Received May 15, 2014

    Report

    Report Number
    2027969-2014-00442
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT NUMBER # 2027969-2014-00442. INRATIO MONITOR (B)(4), PICC LINE WITH HEPARIN, STOPPED HEPARIN FLUSH 10 DAYS AGO;

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULT ARE AS FOLLOWS: SEE SCANNED TABLE. THE TIME BETWEEN TESTING WAS 1 HOUR. THERAPEUTIC RANGE 2.0 - 2.5 FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INVOLVEMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292715 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 333863

    Patients

    Seq Age Sex Outcome Treatment
    1 MARCH, TOOK LAST DOSE, 10 DAYS AGO), COUMADIN| UNSPECIFIED ANTIBIOTICS, (STARTED AT THE END OF