BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5925491 · Received September 2, 2016

    Report

    Report Number
    2027969-2016-00603
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 15, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT 389535A WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED WHEN IT WAS WITHIN EXPIRATION. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. CONFIRMATORY TEST RESULTS WERE NOT PROVIDED. IT IS NOT POSSIBLE TO VERIFY IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016: THE PATIENT REPORTED THE UNEXPECTEDLY HIGH INRATIO INR RESULT OF 4.5 FOLLOWED BY A CHANGE IN WARFARIN DOSAGE BASED UPON THE INRATIO INR RESULT. NO CONFIRMATORY TESTING AVAILABLE. THERAPEUTIC RANGE: 2.0-3.5. THE PATIENT NOTED AIR BUBBLES IN SAMPLE WELL WHEN BLOOD WAS APPLIED TO TEST STRIP. ON (B)(6) 2016: THE PATIENT ALSO REPORTED THE INRATIO ERROR MESSAGES ER 411 X1, UNSPECIFIED QCH X1, AND UNSPECIFIED QCL X1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576255 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 389535A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INRATIO2 PT MONITOR, PN 200432, SERIAL# (B)(4)