BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5740222 · Received June 21, 2016

    Report

    Report Number
    2027969-2016-00466
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 24, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE METER IS NOT RETURNING FOR EVALUATION. THEREFORE, IN-HOUSE TESTING WITH THE REPORTED LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K384106 MET RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT K384106 DID NOT UNCOVER ANY NON-CONFORMANCES. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. 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 VALUES. EVENT OCCURRED IN (B)(6). PATIENT'S THERAPEUTIC RANGE NOT PROVIDED. ON (B)(6) 2016 INRATIO INR = 1.5. ON (B)(6) 2016 INRATIO INR = 1.5; LAB INR = 2.3. ON (B)(6) 2016 INRATIO INR = 2.3; LAB INR = 2.3. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393440 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99007G1 K384106

    Patients

    Seq Age Sex Outcome Treatment
    1