BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2190101 · Received June 30, 2011

    Report

    Report Number
    2027969-2011-01448
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 METER: 3.5 INR, REFERENCE: 2.5 INR, MEAN: 3.00, CONFIDENCE LIMITS: 1.8-4.2. 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. AS OF (B)(6) 2011, NO PRODUCT IS EXPECTED TO RETURN NOR STRIP LOT INFO PROVIDED, UNABLE TO PERFORM IN-HOUSE INVESTIGATION WITHOUT LOT INFO. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: THE RESULTS OF THE ACCURACY COMPARISON WAS NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO TRENDING BY LOT NUMBER IS POSSIBLE SINCE THIS INFO WAS NOT PROVIDED. THIS ISSUE WILL BE TRACKED AND TRENDED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 3.5, LAB: 2.5.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1