BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5832056 · Received July 28, 2016

    Report

    Report Number
    2027969-2016-00538
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K384371 MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. 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

    A VARIANCE WAS REPORTED BETWEEN INRATIO INR RESULTS AND LAB INR RESULT ON A PATIENT IN GERMANY WHO IS NOT ON ANY ANTICOAGULANT. THE RESULTS WERE AS FOLLOWS: DATE: (B)(6) 2016, INRATIO INR: 3.0 AND 3.1, LAB INR: <1.5. NO THERAPEUTIC RANGE SINCE PATIENT IS NOT ON ANTI-COAGULANT. PATIENT IS SCHEDULED TO RECEIVE PHENPROCOUMON MEDICATION. (NOTE: THE INRATIO2 PRODUCT 99008G1 IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO A SAME OR SIMILAR DEVICE BEING AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484187 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K384371

    Patients

    Seq Age Sex Outcome Treatment
    1