BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5261272 · Received December 2, 2015

    Report

    Report Number
    2027969-2015-00979
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION; HOWEVER NO TESTING STRIPS WERE RETURNED. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED, ON THE RETURNED MONITOR, WITH PASSING RESULTS. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED SINCE THE CUSTOMER'S REPORTED INR RESULT COULD NOT BE IDENTIFIED IN THE MONITOR MEMORY. RETAIN STRIPS TESTED ON THE RETURNED MONITOR MET ACCURACY CRITERIA. A REVIEW OF IN-HOUSE TESTING FOR LOT K370018 WAS PERFORMED AND FOUND THAT THE LOT MEETS CRITERIA; NO PRODUCT DEFICIENCY WAS ESTABLISHED FOR THIS LOT. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE IN (B)(6) REPORTED A VARIANCE BETWEEN INRATIO2 INR RESULT AND LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: PATIENT 1: INRATIO2 INR: 3.8, LABORATORY INR: 1.6. THERAPEUTIC RANGE: UNKNOWN. TESTING WAS PERFORMED ONE AFTER THE OTHER. REPORTEDLY, THE STRIP GUIDE OF THE MONITOR WAS STICKY AND DIFFICULT TO INSERT TEST STRIPS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792612 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K370018

    Patients

    Seq Age Sex Outcome Treatment
    1