BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    MDR report key: 5063997 · Received September 9, 2015

    Report

    Report Number
    2027969-2015-00661
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 13, 2015
    Report Date
    August 14, 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 THE ENTIRE IN-HOUSE TESTING HISTORY OF THE REPORTED LOT, K372402, WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K372402 MEETS EXPECTATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT# K372402 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. 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 PHYSICIAN'S OFFICE IN (B)(6) ALLEGED A VARIANCE BETWEEN THE INRATIO2 INR RESULT AND THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: INRATIO2 INR: 1.3, LABORATORY INR: >3.0. THE THERAPEUTIC RANGE AND THE TIME BETWEEN TESTING WAS NOT PROVIDED. 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
    595463 INRATIO2 PT/INR PROFESSIONAL TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K372402

    Patients

    Seq Age Sex Outcome Treatment
    1