BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3963494 · Received May 30, 2014

    Report

    Report Number
    2027969-2014-00515
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. ADDITIONALLY, THE PATIENT IS (B)(6) YEARS OLD. BE ADVISED TESTING HAS BEEN LIMITED TO SUBJECTS AGE 18 AND OLDER. THE CUSTOMER'S OFF-LABEL USE CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR 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. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. 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 ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: INITIAL INRATIO: 1.3. RE-TEST: 3.5. TIME BETWEEN TESTS: WITHIN 2 MINUTES. THERAPEUTIC RANGE: 2.5 - 3.5. WITH THE INITIAL TEST ONLY, THE CUSTOMER MILKED THE FINGER. ADDED MORE THAN ONE DROP OF BLOOD TO THE TEST STRIP, AND THOUGHT IT TOOK LONGER THAN 15 SECOND TO APPLY THE SAMPLE. THE CUSTOMER ALSO TOUCHED THE STRIP WHEN APPLYING THE SAMPLE FOR BOTH TESTS. PATIENT IS UNDER 18 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320104 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 329654

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR COUMADIN: 4MG DAILY| INRATIO MONITOR: SN (B)(4)