BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIP

    MDR report key: 5452404 · Received February 22, 2016

    Report

    Report Number
    2027969-2016-00105
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    January 1, 2016
    Report Date
    January 27, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT WAS ESTIMATED AS (B)(6) 2016 SINCE IT WAS REPORTED THAT THE EVENT OCCURRED SOMETIME IN (B)(6) 2016. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, IN-HOUSE TESTING WAS PERFORMED ON STRIP LOT K380613. RETAIN STRIP TESTING RESULTS MET ACCURACY CRITERIA AND NO PRODUCT DEFICIENCY WAS ESTABLISHED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A ROOT CAUSE COULD NOT BE DETERMINED BY THE INFORMATION PROVIDED. 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 IN (B)(6) REPORTED A VARIANCE BETWEEN THE INRATIO2 INR RESULT AND THE LABORATORY INR RESULT WHICH OCCURRED SOMETIME IN (B)(6) 2016. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2016, INRATIO2 INR: 1.3, LABORATORY INR: 2.2. THE TESTING WAS PERFORMED CONSECUTIVELY; HOWEVER, THE EXACT DATE OF THE TESTING COULD NOT BE PROVIDED. THERAPEUTIC RANGE: UNKNOWN. 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
    109158 INRATIO2 PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K380613

    Patients

    Seq Age Sex Outcome Treatment
    1