BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3971132 · Received April 29, 2014

    Report

    Report Number
    2027969-2014-00387
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNED 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 CRITERIAL. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INDICATE RETURN TESTING, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. 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 INFO 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 RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS." DATE: (B)(6) 2014, INRATIO: 2.0, LAB: 2.09; (B)(6) 2014, 1.9, 3.8. 30 MINUTES BETWEEN TESTS ON (B)(6). TEN MINUTES BETWEEN TESTS ON (B)(6). THERAPEUTIC RANGE: 2.0-3.0. PT SELF TESTER WAS MILKING FINGER AFTER THE FINGER STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256195 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 333863

    Patients

    Seq Age Sex Outcome Treatment
    1 NO CHANGES IN MEDICATION AND DID NOT PROVIDE LIST,| OF MEDICATIONS. MONITOR S/N: (B)(4)