BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2220026 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01542
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: NA, INRATIO: 2.3, REFERENCE: 2.0, MEAN: 2.15, CONFIDENCE LIMITS: 1.4 - 3.1. DATE: NA, 4.9, 4.3, 4.60, 2.5 - 6.5. DATE: NA, 5.0, 3.8, 4.40, 2.5 - 6.5. 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. UNABLE TO PERFORM RETAINED STRIP TEST DUE TO UNK STRIP LOT NUMBER ON THE EVENT DETAILS. NO FURTHER INVESTIGATION IS REQUIRED. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY OF INR TESTING. NO STRIP LOT INFO WAS PROVIDED. NO PRODUCT WAS EXPECTED TO BE RETURNED. 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 USING THE INRATIO METER: RESULTS AS FOLLOWS: INRATIO: 2.3, LAB: 20. 4.9, 4.3. 5.0, 3.8. PT WAS UNSURE ON WHAT DAYS THE CORELATIONS OCCURRED. LESS THAN 5 MINUTES BETWEEN TESTS. PT IS USING AUTOLET WITH 23 GAUGE NEEDLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1