BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5509087 · Received March 17, 2016

    Report

    Report Number
    2027969-2016-00173
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    February 24, 2016
    Report Date
    February 25, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, DONOR TESTING WAS PERFORMED WITH IN-HOUSE MONITORS AND RETAINED TESTINGS STRIPS FOR LOT K382426. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING. IN-HOUSE TESTING REVEALED THAT THE SYSTEM WAS PERFORMING WITHIN EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. ALTHOUGH, THE CUSTOMER REPORTED THAT THE TESTING WAS PERFORMED CORRECTLY ON THE DATE REPORTED, IT WAS ALSO REPORTED THAT THE MONITOR HAD NOT BEEN IN CORRECT MODE DURING PREVIOUS TESTS; THIS MAY CONTRIBUTE TO ERRORS OR UNEXPECTED RESULTS. 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

    REMOVE STATEMENT, "ALTHOUGH, THE CUSTOMER REPORTED THAT THE TESTING WAS PERFORMED CORRECTLY ON THE DATE REPORTED, IT WAS ALSO REPORTED THAT THE MONITOR HAD NOT BEEN IN CORRECT MODE DURING PREVIOUS TESTS; THIS MAY CONTRIBUTE TO ERRORS OR UNEXPECTED RESULTS."

    Description of Event or Problem · 1

    ON 02/25/2016, A PHYSICIAN'S OFFICE IN GERMANY REPORTED THAT THE INRATIO2 INR RESULTS WERE LOWER THAN EXPECTED WITH OTHERWISE STABLE PATIENTS. THE CUSTOMER COULD CONFIRM ONLY ONE COMPARISON. RESULTS ARE AS FOLLOWS: DATE: INRATIO2 INR: LABORATORY INR: (B)(6) 2016, 1.3, 2.3. THERAPEUTIC RANGE: 2.0 - 3.0 THE EXACT TIME BETWEEN TESTING IS UNKNOWN; HOWEVER, THE TESTS WERE PERFORMED ON THE SAME DAY. WHEN DISCUSSING TECHNIQUES WITH THE CUSTOMER, IT WAS REPORTED THAT THE ABOVE TESTING WAS PERFORMED CORRECTLY BUT OTHER TESTING WAS PERFORMED WHEN THE MONITOR WAS IN THE INCORRECT MODE. 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
    164493 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K382426

    Patients

    Seq Age Sex Outcome Treatment
    1