BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1963373 · Received January 10, 2011

    Report

    Report Number
    2027969-2011-00042
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2010; 1ST INR = 2.6; 2ND INR = 3.3; 3RD INR = 3.2; MEAN = 3.03; SD = 0.38; %CV = 12.48. CUSTOMER UTILIZED TWO DIFFERENT STRIP LOTS ON UNIT, BUT NO INDICATION OF TECHNIQUE OR USER ISSUE. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON MET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED. NO STRIP LOT INFO WAS AVAILABLE. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; STRIP: 1; INRATIO: 2.6. DATE: (B)(6) 2010; STRIP: 2; INRATIO: 3.3; RE-TEST: 3.2. PT SELF TESTER USED TWO DIFFERENT STRIP LOTS FOR TESTING.

    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