BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5746952 · Received June 23, 2016

    Report

    Report Number
    2027969-2016-00470
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 28, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE TESTING ON THE REPORTED STRIP LOT MET RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED; THE LOT MET RELEASE SPECIFICATIONS. UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. IN-HOUSE TESTING ON THE RETURNED MONITOR USING RETAINED TEST STRIPS MET ACCURACY CRITERIA. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE RETURNED MONITOR PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. THE SYSTEM PERFORMED WITHIN EXPECTATIONS. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVE GENERATED USING THE CUSTOMER'S REPORTED INRATIO INR RESULT DETERMINED THAT THE CURVE WAS NORMAL IN SHAPE AND DID NOT EXHIBIT A WEAK OR ABNORMAL SLOPE. UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT. 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

    VARIANCE WAS REPORTED BETWEEN INRATIO INR RESULT, LAB INR RESULT AND ALTERNATE POC INR RESULT. THE RESULTS WERE AS FOLLOWS: ON (B)(6) 2016: INRATIO INR = 2.4. ON (B)(6) 2016: LAB INR = 1.4.(VENOUS DRAW AT HOSPITAL). ON (B)(6) 2016: ALTERNATE POC INR = 1.3 (FINGERSTICK AT CARDIOLOGIST'S OFFICE). REPORTED THERAPEUTIC RANGE = 2.0-3.0. WARFARIN WAS DISCONTINUED BY CARDIOLOGIST ON (B)(6) 2016; PATIENT WAS PRESCRIBED XARELTO (DOSE NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401288 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 384614A

    Patients

    Seq Age Sex Outcome Treatment
    1