BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5246321 · Received November 24, 2015

    Report

    Report Number
    2027969-2015-00961
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Report Date
    November 3, 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/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, IN-HOUSE RETAIN TESTING WAS PERFORMED. AN ANALYSIS OF THE IN-HOUSE TESTING RESULTS FOR LOT K373667 DETERMINED THAT THE LOT MET EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A 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.

    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 RESULTS USING TWO DIFFERENT INRATIO MONITORS. RESULTS ARE AS FOLLOWS: PATIENT 3: INRATIO2 INR MONITOR 1: 1.2, INRATIO2 INR MONITOR 2: UNKNOWN. THERAPEUTIC RANGE: 2.0 - 3.0. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS BEING CONSERVATIVELY FILED AS THERE WERE 3 PATIENTS WITH THE SAME INRATIO2 MONITOR RESULT. THE OTHER 2 PATIENTS ARE BEING REPORTED UNDER SEPARATE MEDWATCH FORMS. (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
    776347 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K373667

    Patients

    Seq Age Sex Outcome Treatment
    1