BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    MDR report key: 5018907 · Received August 20, 2015

    Report

    Report Number
    2027969-2015-00605
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 4, 2015
    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 IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K370018 MET RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT K370018 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. 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

    A PHYSICIAN'S OFFICE IN (B)(6) ALLEGED A VARIANCE BETWEEN THE INRATIO2 INR RESULT AND THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO2 INR: 1.2 AND 1.2, LABORATORY INR: 2.0. THERAPEUTIC RANGE: NOT PROVIDED. TESTING WAS PERFORMED ONE AFTER THE OTHER. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THE INRATIO2 PRODUCT 99008G1 IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO THE A SAME OR SIMILAR DEVICE BEING AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552226 INRATIO2 PT/INR PROFESSIONAL TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K370018

    Patients

    Seq Age Sex Outcome Treatment
    1