BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4993827 · Received August 11, 2015

    Report

    Report Number
    2027969-2015-00581
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. HOWEVER, TREND CODE ANALYSIS IS PERFORMED EACH MONTH.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULT IN COMPARISON TO THE LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: 6/19 INRATIO=2.4; 7/1 LAB=5.2. THE PATIENT SELF TESTER'S THERAPEUTIC RANGE IS: 2.0-3.0. PATIENT SELF TESTER WENT TO THE HOSPITAL ON 7/1 FOR A NOSE BLEED; HE WAS NOT ADMITTED TO THE HOSPITAL BUT HE STAYED THERE FOR A COUPLE OF HOURS AND THEY PACKED HIS NOSE. THE LAB INR=5.2; HOWEVER, NO OTHER TREATMENTS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527061 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INRATIO MONITOR SN: (B)(4)