BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4122118 · Received September 18, 2014

    Report

    Report Number
    2027969-2014-00854
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 STRIP REPEATABILITY CRITERIA. A REVIEW OF THE MANUFACTURER RECORD FOR THE LOT DID NOT UNCOVER ANY RELEVANT NONCONFORMANCE. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFO PROVIDED. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH PHYSICIAN'S INRATIO METER AND THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2014; PATIENT'S INRATIO: 3.8; PHYSICIAN'S INRATIO: 2.6; LAB: 2.8. ALL THREE TESTS WERE DONE WITHIN 20 MINUTES. PATIENT SELF TESTER'S THERAPEUTIC RANGE: 3.0-3.5. PATIENT SELF TESTER IS MILKING FINGER AFTER FINGERSTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579403 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 348355

    Patients

    Seq Age Sex Outcome Treatment
    1 DIGOXIN 125MCG| DAILY VITAMIN| DILITIAZEM 120MG/DAY| WARFARIN (JANTOVEN)| METOPROLOL TARTRATE| MONITOR: SN, (B)(4)