BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5535478 · Received March 30, 2016

    Report

    Report Number
    2027969-2016-00202
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 5, 2016
    Report Date
    March 2, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    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

    ADDITIONAL INFORMATION: (B)(6) 2016 INRATIO INR = 3.4; PATHOLOGY INR = 3.0. 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 INR = 7.5; PATHOLOGY INR = 4.9. PATIENT'S THERAPEUTIC RANGE 2 - 3. IT WAS REPORTED THE PATIENT WAS SENT TO THE HOSPITAL AND THEIR WARFARIN DOSE WAS DROPPED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION PROVIDED REGARDING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191631 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS99008G1 K381677

    Patients

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