BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6120790 · Received November 22, 2016

    Report

    Report Number
    2027969-2016-00689
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Report Date
    October 26, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, IN-HOUSE TESTING WITH RETAINS OF THE REPORTED LOT WAS PERFORMED. IN-HOUSE STRIP TESTING ON STRIP LOT K392893 MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. ALTHOUGH A TECHNIQUE ISSUE WAS IDENTIFIED, 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. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED OF DISCREPANT INRATIO VALUES. EVENT OCCURRED IN (B)(6). PATIENT'S THERAPEUTIC RANGE 2 - 3. PATIENT REPORTS TWO DISCREPANT INRATIO INR RESULTS COMPARED TO LABORATORY INR. TESTS TAKEN DURING A 4 WEEK REHABILITATION PERIOD IN A REHAB CLINIC (REASON FOR REHAB UNKNOWN). DATES FOR TESTS NOT PROVIDED. NUMBER OF DAYS BETWEEN THE TWO TEST RESULTS UNKNOWN. RESULT 1: INRATIO INR = 1.7; LAB INR = 2.5. RESULT 2: INRATIO INR = 2.6; LAB INR = 1.3. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771135 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K392893

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SERIAL # (B)(4)