BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4092540 · Received August 19, 2014

    Report

    Report Number
    2027969-2014-00764
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECS AND NO NON-CONFORMANCES 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

    CALLED ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: INRATIO: 5.2; RE-TEST: 4.5; LAB: 3.4. THE CUSTOMER INDICATED SHE HAD A LABORATORY TEST TAKEN TODAY (3.4), AND THEN APPROX 10 MINUTES LATER SHE USED HER INRATIO MONITOR AND OBTAINED A RESULT OF 5.2. THINKING THIS RESULT WAS HIGH, SHE RETESTED HERSELF 20 MINUTES LATER USING A DIFFERENT FINGER AND OBTAINED AN INRATIO RESULT OF 4.5. THERAPEUTIC RANGE: 2.5-3.5. THE PT SELF TESTER REPORTS TOUCHING THE DROP OF BLOOD ONTO THE STRIP. FOLLOW UP TESTING WAS PERFORMED WITH THE FOLLOWING RESULTS: INRATIO: 4.2; LAB: 3.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500211 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC HS099007EU K339920

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN,| MEDICATIONS: CONTRACEPTIVE PILL,| ANTI-INFLAMTORY