BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3853149 · Received April 2, 2014

    Report

    Report Number
    2027969-2014-00289
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ON INRATIO STRIPS WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND PRODUCT DEFICIENCIES WERE NOT OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER USE OF THE METER AND 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. 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: (B)(6) 2014: INRATIO = 1.4, 3.1; (B)(6) 2014: INRATIO = 5.0, 4.7; 2 HOURS BETWEEN TESTS ON (B)(6) 2014; 5 MINS BETWEEN TESTS ON 03/12/2014. THERAPEUTIC RANGE: 2.5-3.5. METER WAS IN PATIENT'S LAP WHILE TESTING ON (B)(6) 2014. METER WAS IN DAUGHTER'S HAND DURING APPLICATION, THEN WAS PLACED ON A TABLE ON (B)(6) 2014. METER NOT IN CORRECT MODE WHEN FINGERSTICK PERFORMED; MILKING FINGER AFTER FINGERSTICK; SAMPLE NOT APPLIED IMMEDIATELY AFTER FINGERSTICK; TOUCHED FINGER TO SAMPLE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200528 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 333790

    Patients

    Seq Age Sex Outcome Treatment
    1