BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5534925 · Received March 30, 2016

    Report

    Report Number
    2027969-2016-00201
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 2, 2016
    Report Date
    March 2, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K381677 WAS FOUND TO BE PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT K381677 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

    EVENT OCCURRED IN (B)(6). REPORT OF DISCREPANT INRATIO INR VALUE. ON (B)(6) 2016 INRATIO 3.2; PATHOLOGY INR 1.6. PATIENT'S THERAPEUTIC RANGE 2 - 3. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192040 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS99008G1 K381677

    Patients

    Seq Age Sex Outcome Treatment
    1