BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5998364 · Received October 4, 2016

    Report

    Report Number
    2027969-2016-00638
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 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
    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 K387870 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. 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

    THE PATIENT REPORTED THE FOLLOWING DISCREPANT HIGH INRATIO INR RESULTS: ON (B)(6) 2016: INRATIO INR RESULT= 2.6. ON (B)(6) 2016: INRATIO INR RESULT= 2.7. ON (B)(6) 2016: INRATIO= 2.7, LAB= 1.7, INRATIO= 2.7, 2.4 (EXACT TIMING BETWEEN TESTS IS UNKNOWN BUT FIRST THREE TESTS CONDUCTED IN MORNING AND LAST TEST CONDUCTED IN AFTERNOON). THERAPEUTIC RANGE: 2.5 - 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647593 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K387870

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO2 PT MONITOR, PN 200433, SERIAL# (B)(4)