BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4863982 · Received June 23, 2015

    Report

    Report Number
    2027969-2015-00438
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 19, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    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: (B)(6) INRATIO INR=3.7, REDUCED COUMADIN FROM 10MG DAILY TO ALTERNATING 7.5MG AND 10MG DAILY. (B)(6) LAB INR= 5.7 WITHHELD COUMADIN ENTIRELY PER LAB RESULT AND PATIENT SELF TESTER ALSO INDICATED HE HAD AN UNUSUALLY LARGE SALAD AFTER THE LAB TEST. (B)(6) INRATIO INR= 3.4 COUMADIN DOSE PRIOR TO (B)(6) WAS 10 MG DAILY. PATIENT SELF TESTER'S THERAPEUTIC RANGE: 2.5-3.5. PATIENT SELF TESTER MILKING FINGER AFTER FINGERSTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404746 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| INRATIO MONITOR SN: (B)(4)