BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2100151 · Received May 12, 2011

    Report

    Report Number
    2027969-2011-01068
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: SEE SCANNED TABLE. 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. DISCREPANT RESULTS (PRECISION) COMPARISON OF INRATIO TEST RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 5.4, INRATIO: 5.8, MEAN: 5.6, SD: 0.283, %CV: 5.05, RESULT: PASS. SINCE % CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. THE RESULTS ARE NOT CONSIDERED DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 247451 ON (B)(4) 2011. RESULTS AS FOLLOWS: INRATIO: 2.2, INRATIO: 2.1, REFERENCE: 1.97, BIAS THRESHOLD: 1.47-2.47. INRATIO: 4.2, 3.7, 4.2, REFERENCE: 2.91, BIAS THRESHOLD: 1.91-3.91. 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. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM THE REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON MET PRECISION CRITERIA. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. (B)(4). STRIP LOT IN COMPLAINT HAS STRIP CODE 62935 WHICH BRICK LOT NUMBER 237418 WAS ASSIGNED AND PACKAGED INTO STRIP LOTS (247450 AND 247451). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), 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

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: THERAPEUTIC RANGE IS: 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1