BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1942189 · Received December 21, 2010

    Report

    Report Number
    2027969-2010-02224
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPRESSION OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2010, INRATIO: 3.2, PREFERENCE: 2.6, MEAN: 2.9, CONFIDENCE LIMITS: 1.8 - 4.2. DATE: (B)(6) 2010, INRATIO: 4.6, REFERENCE: 3.3, MEAN: 3.95, CONFIDENCE LIMITS: 2.3 - 5.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS 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. DATE: (B)(6) 2010, INRATIO: 5.8, REFERENCE: 4.4, MEAN: 5.1, CONFIDENCE LIMITS: NA. THE MEAN IS >5.0 AND THE DIFFERENCE IS LESS THAN 2.2. AND ONLY ONE INR VALUE IS GREATER THAN 5.0. THESE RESULTS ARE CONSIDERED ACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO FURTHER INVESTIGATION IS REQUIRED. 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 FOR INR TESTING. AS REVIEWED ON 12/21/2010, 54 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #234526 YIELDING A COMPLAINT RATE OF 0.045%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO 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. ON (B)(6) 2010, LAB RESULTS WERE WITHIN 45 MINS OF INRATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234526

    Patients

    Seq Age Sex Outcome Treatment
    1