BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4801873 · Received May 28, 2015

    Report

    Report Number
    2027969-2015-00372
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 6, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES AND THE LOT MET RELEASE SPECIFICATION. THE CUSTOMER WAS REPORTED TO HAVE A HISTORY OF ANEMIA, BUT DID NOT BELIEVE THAT SHE WAS CURRENTLY ANEMIC. A CURRENT HEMATOCRIT VALUE WAS NOT PROVIDED. ANEMIA MAY IMPACT PATIENT'S HEMATOCRIT. ACCURACY IS VALIDATED FOR HEMATOCRIT VALUES BETWEEN 30% AND 55%. A HEMATOCRIT OUTSIDE THIS RANGE MAY CAUSE AN INACCURATE RESULT OR ERROR MESSAGE. ADDITIONALLY, CERTAIN RELEVANT CONDITIONS, SUCH AS ANEMIA WITH A HEMATOCRIT OF LESS THAN 30%, HAS BEEN IDENTIFIED AS A CONDITION THAT MAY CONTRIBUTE TO A DISCREPANT INR RESULT. THE ROOT CAUSE IS UNABLE TO BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULT AND AN ALTERNATE POINT OF CARE (POC) INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO INR: 1.5, POC INR: N/A. (B)(6) 2015, N/A, 2.3. THERAPEUTIC RANGE: 2.0 - 3.0. THE CALLER REPORTED A HISTORY OF ANEMIA BUT DOES NOT BELIEVE THAT SHE IS CURRENTLY ANEMIC; HOWEVER, NO RECENT BLOOD WORK WAS PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346848 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 355822

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER UNSPECIFIED MEDICATIONS| COUMADIN| UNSPECIFIED POC INR MONITOR AND TESTING STRIPS| PROTONIX| INRATIO MONITOR SN UNKNOWN