BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5015705 · Received August 19, 2015

    Report

    Report Number
    2027969-2015-00602
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION; NO TEST STRIPS WERE PROVIDED. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. RETAIN STRIP TESTING, WITH LOT K370019 ON THE RETURNED MONITOR, MEETS CRITERIA. THE MONITOR PERFORMED AS EXPECTED DURING IN-HOUSE INVESTIGATION. THE MONITOR MEMORY RETAINS IMPEDANCE CURVE DATA FOR THE LAST FOUR (4) RESULTS. SINCE THE REPORTED INRATIO INR RESULT OF 1.1 WAS NOT IN THE LAST FOUR (4) RESULTS, THE IMPEDANCE CURVE COULD NOT BE ANALYZED. A REVIEW OF THE TESTING HISTORY FOR STRIP LOT NUMBERS K370019 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET CRITERIA AND THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED. THE MANUFACTURING RECORDS FOR THE STRIP LOT WERE REVIEWED AND MET RELEASE SPECIFICATIONS. THE 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 AND NO CORRECTIVE ACTION IS REQUIRED.

    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: 1.1; 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
    549707 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K370019

    Patients

    Seq Age Sex Outcome Treatment
    1