BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6038416 · Received October 18, 2016

    Report

    Report Number
    2027969-2016-00652
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 21, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE STRIP TESTING ON STRIP LOT K381677 MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMER COULD NOT INDICATE WHETHER THE SYRINGE USED WAS FREE OF ANTICOAGULANTS. USE OF A SYRINGE TREATED WITH ANTICOAGULANTS MAY LEAD TO UNEXPECTED RESULTS OR TESTING ERRORS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED OF DISCREPANT INRATIO VALUE. EVENT OCCURRED IN (B)(6). PATIENT'S THERAPEUTIC RANGE UNKNOWN. ON (B)(6) 2016 INRATIO INR >7.5; LAB INR 2.49. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689560 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K381677

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SERIAL #(B)(4)