BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3492443 · Received October 25, 2013

    Report

    Report Number
    2027969-2013-00964
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    October 4, 2013
    Report Date
    October 4, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. AS REVIEWED ON (B)(4) 2013, 33 DISCREPANT COMPLAINS HAVE BEEN REPORTED FOR THE PRODUCTION LOT # 315108 YIELDING A COMPLAINT RATE OF 0.04%. DUE TO THESE LOW OCCURRENCE RATES, BELOW THE ACTION THRESHOLD MONITORED BY QA, NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRES AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" LOT 1 INRATIO = 4.9; LOT 2 INRATIO = 2.0. CALLER REPORTED LOT TO LOT VARIABILITY. PATIENT SELF TESTER TESTED ON ONE LOT OF STRIPS (LAST STRIP IN THE BOX) AND RECEIVED A 4.9 (LOT # 304239). SHE BELIEVED THIS WAS TOO HIGH SO SHE OPENED A NEW BOX AND RECEIVED A 2.0 (LOT #315108). TIME BETWEEN TESTS: 5 MINUTES. THERAPEUTIC RANGE: 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550458 INRATIO PROTHROMBIN TIME SHEET GJS ALERE SAN DIEGO, INC 100071 304239

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN