BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2213874 · Received August 5, 2011

    Report

    Report Number
    2027969-2011-01745
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS TAKING ASPIRIN. PATIENT'S CURRENT MEDICATION MAY CONTRIBUTE TO UNEXPECTED OR INACCURATE INR RESULT. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2011, 1ST INR: 3.7, 2ND INR: 3.3, 3RD INR: 2.8, MEAN: 3.27, SD: 0.45, %CV: 13.80; 4.2 AND 2.3 INR ARE EXCLUDED FROM COMPARISON TEST. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. CUSTOMER WAS COMPARING TEST RESULTS THAT OCCURRED MORE THAN 3 HOURS APART. IF TIME ELAPSED EXCEEDS 3 HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. ANALYSIS OF THE CLIENT'S VALID DATA FROM REPEATED INRATIO TESTS (INR = 3.7, 3.3 AND 2.8) REVEALED THAT TEST RESULT COMPARISON MET PRECISION CRITERIA. PT'S MEDICATION CANNOT BE RULED OUT AS A CAUSE FOR THE EXPECTED RESULTS. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST ((B)(6) 2011) RESULT COMPARISON MET PRECISION CRITERIA. (B)(4). CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.2 (REDUCED COUMADIN DOSE). DATE: (B)(6) 2011, INRATIO: 2.3. DATE: (B)(6) 2011, TIME: BEFORE 8AM, INRATIO: 3.7. DATE: (B)(6) 2011, TIME: BEFORE 10AM, INRATIO: 3.3, DOCTOR'S INRATIO: 2.8. PT TOOK THEIR COUMADIN DOSE FOR THE DAY AFTER TESTING ON THE INRATIO METER AT 8:00 IN THE MORNING. WENT TO THEIR DOCTOR'S OFFICE AND TESTED ON THE PT'S METER, THEN USING THE SAME FINGER (NEW PUNCTURE, WITHIN MINUTES) ON DOCTOR'S INRATIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1