BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3082618 · Received April 23, 2013

    Report

    Report Number
    2027969-2013-00331
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS ANEMIC BUT HEMATOCRIT IS UNKNOWN. PT CURRENT HEALTH STATUS MAY AFFECT COAGULATION TEST. BE ADVISED, HEMATOCRIT RANGES BETWEEN 30-55% WILL NOT AFFECT TEST RESULTS. ADDITIONALLY, CUSTOMER WAS MILKING THE FINGER. MILKING THE FINGER MAY CAUSE CONTAMINATION WITH INTERSTITIAL FLUIDS AND MAY LEAD TO INACCURATE INR RESULT OR TESTING ERROR. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2013, 1ST INR = 1.1, 2ND INR = 2.0, MEAN = 1.55, SD = 0.636; %CV = 41.1. INRATIO METER RESULTS FAILED THE CRITERIA FOR PRECISION WITH %CV GREATER THAN 20%. PS WAS UNABLE TO PERFORM FURTHER INVESTIGATION DUE TO UNKNOWN STRIP LOT NUMBER ON THE EVENT DETAILS AND NO PRODUCT RETURN. FURTHER INVESTIGATION WS NOT POSSIBLE. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFORMATION. IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT. THIS COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. PT WAS IDENTIFIED AS BEING ANEMIC. PT'S CONDITION COULD HAVE CONTRIBUTED TO UNEXPECTED RESULTS. AS STATED IN THE PRODUCT INSERT, INRATIO HAS LIMITATION THAT HEMATOCRIT RANGES 30-55% HAVE BEEN SHOWN TO NOT AFFECT TEST RESULTS. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO TEST 1: 1.1; INRATIO TEST 2: 2.0. TIME BETWEEN TESTING WAS REPORTED AS 5 MINUTES. PT'S THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175358 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN