BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4142551 · Received September 30, 2014

    Report

    Report Number
    2027969-2014-00890
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULTS IN COMPARISON TO THE LABORATORY INR RESULT AND ALTERNATE POINT OF CARE (POC) INR RESULTS. ON (B)(6) 2014, THE PATIENT VISITED THE EMERGENCY ROOM FOR BLEEDING FROM UNSPECIFIED BIOPSY SITE. DETAILS OF BIOPSY WERE NOT PROVIDED. LABORATORY INR IN THE EMERGENCY ROOM WAS 4.1. THE WOUND WAS CAUTERIZED AND THE PATIENT WAS SENT HOME. THE PATIENT REPORTS THAT SHE "THINKS" THE PHYSICIAN TOLD HER TO HOLD HER COUMADIN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ON (B)(6)2014, THE INRATIO INR WAS 2.0 AND 2.1 IN COMPARISON TO THE ALTERNATE POC OF 4.0 AND 4.1. THE TESTING WAS PERFORMED SIMULTANEOUSLY. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608283 INRATIO PT/INR TEST STRIPS PROTHOMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 348355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INRATIO MONITOR SN (B)(4), COAGUCHEK,| COUMADIN, TYLENOL, UNSPECIFIED THYROID MEDICATION