BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1894144 · Received November 4, 2010

    Report

    Report Number
    2027969-2010-01851
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 10, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAD DIALYSIS. PT CURRENT HEALTH STATUS MAY AFFECT COAGULATION TEST AND MAY LEAD TO UNEXPECTED OR INACCURATE INR RESULT. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2010; INRATIO: 1.8; REFERENCE: 1.5; MEAN: 1.65; CONFIDENCE LIMITS: 1.2 - 2.3. THE 2.4, 2.8, 3.9 AND 2.2 INR ARE EXCLUDED FROM COMPARISON TEST. SINCE TIME OF TEST EXCEEDED THREE HRS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HRS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: NG; 1ST INR: 1.5; 2ND INR: 1.2; 3RD INR: 1.3; MEAN: 1.33; SD: 0.15. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PT WAS REPORTEDLY HAVING DIALYSIS. NO STRIP LOT INFO WAS AVAILABLE. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: LAST 2-3 WEEKS INRATIO: 1.5,1.2,1.3, LAB -. DATE: (B)(6) 2010: INRATIO: 2.4, LAB -. DATE: (B)(6) 2010: INRATIO: -, LAB: 2.8. CUSTOMER BROUGHT HIS INRATIO METER TO HIS DOCTOR'S OFFICE TO BE TESTED. DATE: (B)(6) 2010; INRATIO: 1.8; CLINIC'S METER: 1.5. ONE FINGER WAS USED FOR TESTING, THE FIRST DROP WAS TESTED ON PT METER SECOND DROP ON MD'S METER. PT TESTED USING THE INRATIO METER, WITH THE FOLLOWING RESULTS. DATE: (B)(6) 2010; INRATIO: 3.9. DATE: (B)(6) 2010; INRATIO: 2.2 (S/P DIALYSIS).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1