BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4842168 · Received June 12, 2015

    Report

    Report Number
    2027969-2015-00408
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 22, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: AS OF (B)(6) 2015, THE PRODUCT HAS NOT RETURNED FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A 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. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULTS AND THE PHYSICIAN'S POINT OF CARE (POC) INR RESULT. THE CUSTOMER REPORTED THAT ON (B)(6) 2015, SHE TESTED AND HER INR WAS 4.0 (DIFFERENT STRIP LOT THAN THE FOLLOWING RESULTS, AND NO LOT NUMBER PROVIDED). THE THERAPEUTIC RANGE WAS 2.0 - 3.0. AT THAT TIME, HER INSTRUCTIONS WERE TO HOLD HER COUMADIN DOSE ON (B)(6) 2015 AND (B)(6) 2015, THEN ON (B)(6) 2015 RESUME COUMADIN 10MG. SHE STATED THAT SHE ATE A LOT OF GREEN DURING THAT TIME. ON (B)(6) 2015, WITH THE LOT NUMBER ON THIS REPORT, HER INRATIO INR WAS >7.5 AND >7.5. SHE FOLLOW UP WITH HER PHYSICIAN, AT THE OFFICE, APPROXIMATELY TWO (2) TO THREE (3) HOURS LATER AND THE PHYSICIAN'S POINT OF CARE (POC) INR WAS 1.3 . THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385178 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 344097

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR