BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4110275 · Received September 12, 2014

    Report

    Report Number
    2027969-2014-00841
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. RETAIN STRIP TESTING RESULT MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS 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

    CALLER ALLEGED DISCREPANT INRATIO INR RESULT. RESULTS AS FOLLOWS: INRATIO: 1.3. LAB: 2.8. TIME BETWEEN TESTS: ONE HOUR. THERAPEUTIC RANGE: 2.5-3.0. CALLER REPORTS MILKING THE FINGER AFTER FINGER STICK AND ADDING MULTIPLE DROPS OF BLOOD TO THE STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566718 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 347476

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR (B)(4)| LEVOTHYROXINE| AMIODARONE| WARFARIN| LEVETIRACETAM