BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2130371 · Received May 9, 2011

    Report

    Report Number
    2027969-2011-01018
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT WITH LAB RESULT PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 5.4, REF: 3.3, MEAN: 4.35, CONFIDENCE LIMITS: 2.4 - 6.1, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. IN-HOUSE TESTING HAS BEEN PERFORMED ON REPORTED LOT 241836 ON 02-MAY-2011. RESULTS AS FOLLOWS: INRATIO: 2.4, INRATIO: 2.7, INRATIO: 2.8, REFERENCE: 2.82, BIAS THRESHOLD: 1.82 - 3.82. INRATIO: 2.9, INRATIO: 3.0, INRATIO: 2.7, REFERENCE: 2.56, BIAS THRESHOLD: 1.56 - 3.56. THE MINIMUM TWO OUT OF THREE REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. PATIENT ON ANTIBIOTICS COULD HAVE CONTRIBUTED TO UNEXPECTED RESULT. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (B)(4). ACTION THRESHOLD HAS REACHED. SINCE STRIP LOT RELEASED, SIX IN-HOUSE THERAPEUTIC SAMPLE TESTS HAVE BEEN PERFORMED FOR RETAINED AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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: DATE: (B)(6) 2011, INRATIO: 5.4, LAB: 3.3. LAB RESULT DRAWN WITHIN 5 MINUTES OF METER RESULT. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. PATIENT WAS TAKING ANTIBIOTICS FOR 11.5 DAYS UNTIL (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1