BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4171031 · Received July 14, 2014

    Report

    Report Number
    2027969-2014-00656
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. 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 DEVIANCIES WERE OBSERVED. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECS AND NO NON-CONFORMANCE WERE DOCUMENTED. 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 INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; IN RATIO INR: 5.1; LABORATORY INR: 1.6. THERAPEUTIC RANGE: 2.0-3.0. THE TIME BETWEEN TESTING WAS ONE (1) - TWO (2) HOURS. THE CALLER WAS NOT THE INDIVIDUAL WHO RAN THE TEST; THEREFORE, WAS UNABLE TO PROVIDE PT INFO OR TECHNIQUE INFO. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410952 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 344683

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN UNK