BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3862869 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00139
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. A REVIEW OF THE BATCH RECORD FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. RESULTS OF THE QUERY OF SIMILAR INCIDENT IN THE COMPLAINT SYSTEM FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURNED TESTING, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: INRATIO2: 1.6, RE-TEST: 2.7. TIME BETWEEN TESTS: < 2 MINUTES. THERAPEUTIC RANGE: 2.5-3.5. PATIENT SELF TESTER REPORTS THEY PERFORMED 2 FINGER STICKS ON THE SAME FINGER. CUSTOMER WAS UNABLE TO OBTAIN A LARGE ENOUGH DROP TO TEST ON THE FIRST FINGER STICK. THEY THEN PERFORMED A NEW FINGER STICK, TESTED AND RECEIVED A 1.6. THEY WERE CONCERNED WITH THAT READING SO THEY CLEANED THE FINGER AND SQUEEZED OUT A SECOND SAMPLE USING THE SAME FINGER STICK, INR= 2.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104349 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 329655

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN