BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2003819 · Received February 7, 2011

    Report

    Report Number
    2027969-2011-00262
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.3 INR, REFERENCE: 2.8 INR, MEAN: 2.05, CONFIDENCE LIMITS: 1.3-2.7; (B)(6) 2011, 1.2 INR, 1.4 INR, 1.30, 1.0-1.5. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. REFERENCE VALUE OF TEST 1 FALLS OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. AS OF FEBRUARY 7, 2011, NO STRIP INFO NOR PRODUCT IS EXPECTED TO RETURN. UNABLE TO PERFORM IN-HOUSE INVESTIGATION. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. "MILKING OF FINGER" FOR SAMPLE WOULD BE CONSIDERED IMPROPER TECHNIQUE. RESULT FROM SUCH TECHNIQUE COULD BE INACCURATE. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT ONE OUT OF TWO TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. NO STRIP LOT INFO WAS AVAILABLE. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. ON CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: PT 1, DATE: (B)(6) 2011, INRATIO: 1.3, LAB: 2.8; PT 2, (B)(6) 2011, 1.2, 1.4. LAB DRAWS DONE 15 MINUTES AFTER RESPECTIVE INRATIO METER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 NG

    Patients

    Seq Age Sex Outcome Treatment
    1