BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3770240 · Received March 10, 2014

    Report

    Report Number
    2027969-2014-00205
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 28, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED DISCREPANT LOW INRATIO INR RESULTS DURING TESTING. THE CUSTOMER DID NOT PROVIDE A REFERENCE VALUE FOR COMPARISON TESTING FOR THE INRATIO INR RESULT ON (B)(6) 2014. THE ACCURACY OF THE INRATIO INR RESULT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. 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. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. NO FURTHER INVESTIGATION WAS PERFORMED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2014, INRATIO: 1.8; (B)(6) 2014, 2.1, PHYSICIAN POC: 5.7 (30 MINUTES BETWEEN TESTS). THERAPEUTIC RANGE: 2.5-3.5. PATIENT SELF TESTER PERFORMED A TEST ON A NON COUMADIN PERSON; INRATIO= 1.2. NORMAL INR RANGE IS 0.7-1.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143611 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 332829

    Patients

    Seq Age Sex Outcome Treatment
    1