BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3822912 · Received February 18, 2014

    Report

    Report Number
    2027969-2014-00132
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. 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

    CALLER ALLEGING RECEIVING DISCREPANT INRATIO VALUES. (B)(6) 2014. INRATIO 1.3, REPEAT INRATIO 4.7, REPEAT INRATIO 4.6. APPROXIMATELY TEN MINUTES BETWEEN TESTING. PATIENT'S THERAPEUTIC RANGE 2.5 - 3.0. PATIENT OBTAINED AN INRATO OF 1.6 ON (B)(6) 2014. AS A RESULT, THE CARDIOLOGIST INCREASED HIS COUMADIN FROM 2MG/DAY TO 4 MG/DAY FOR TWO DAYS ((B)(6)). HE THEN WENT BACK TO 2 MG/DAY ON (B)(6). HE TESTED (B)(6) 2014 AND OBTAINED A RESULT OF 1.3. THIS SEEMED TOO LOW, SO HE RE-TESTED TEN MINUTES LATER ON A NEW FINGER AND OBTAINED AN INR OF 4.7. APPROXIMATELY TEN TO FIFTEEN MINUTES LATER, HE TESTED AGAIN ON ANOTHER NEW FINGER AND OBTAINED AN INR OF 4.6. PATIENT SELF TESTER NOTES ON THE LOWER RESULTS HE WAS USING THE AUTO-LANCET AND HAD DIFFICULTY PENETRATING THE SKIN ON HIS FINGER AND GETTING THE BLOOD, AND MAY HAVE HAD TO MILK THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100866 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 319199

    Patients

    Seq Age Sex Outcome Treatment
    1 PAROXETINE| OMEPRAZOLE (20 MG/DAY)| BENADRYL| AMLODIPINE (5 MG/DAY)| CARVEDILOL (25 MG/DAY)| BUPROPION (150 MG) AMBIEN| COUMADIN 2MG/DAY| CHLORODIAZEPAM 5 MG, 3-4X DAILY| CITALOPRAM