BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 4213411 · Received October 23, 2014

    Report

    Report Number
    2027969-2014-00969
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE A LABORATORY REFERENCE VALUE FOR COMPARISON. UNABLE TO DETERMINE THE ACCURACY OF THE INRATIO RESULT WITHOUT THIS INFORMATION. IT IS INDICATED THAT THE 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 STRIP REPEATABILITY CRITERIA. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. A REVIEW OF THE MANUFACTURER RECORD FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCE. LOT MEETS RELEASE SPECIFICATION. ROOT CAUSE IS UNABLE TO BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT SELF TESTER CALLED ALLEGING RECEIVING DISCREPANT INRATIO VALUE. ON (B)(6) 2014, INRATIO >7.5. PATIENT SELF TESTER RETESTED INRATIO WITH SUPPORT STAFF USING PROPER TECHNIQUE AND OBTAINED RESULT OF 1.7. TEST PERFORMED ONE HOUR AFTER INITIAL INRATIO RESULT. PATIENT'S THERAPEUTIC RANGE 2-2.5. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675929 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 348355

    Patients

    Seq Age Sex Outcome Treatment
    1 TYLENOL| WARFARIN| INRATIO MONITOR SERIAL # (B)(4)