BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3862868 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00141
    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
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. CORRECTIVE ACTION IS NOT 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: DATE: NOT GIVEN, INRATIO: 1.8, LAB: 2.3. DATE: NOT GIVEN, INRATIO: 2.4, LAB: 4.4. LAB DRAWS WERE PERFORMED WITHIN MINUTES OF THE FINGER STICK. THERAPEUTIC RANGE: 2.5-3.0. COMPARISONS WERE DONE ON DIFFERENT DAYS USING TWO DIFFERENT INRATIO2 METERS. CUSTOMER COULD NOT PROVIDE METER SERIAL NUMBERS OR TEST DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104314 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 328109

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN