BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1894133 · Received November 4, 2010

    Report

    Report Number
    2027969-2010-01879
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: (B)(6) 2010; INRATIO: 7.5; REFERENCE: 3.4; MEAN: 5.45; CONFIDENCE LIMITS: NA. THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADDITIONAL INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT #232170 FROM ANOTHER CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST (B)(4) REPLICATES FOR BOTH SAMPLES FOR STRIP LOT #232170 ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0). NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. ONE OUT OF TWO TOTAL NORMAL DONOR TEST RESULTS WERE OUT OF RANGE. COMPLAINT DID NOT CONTAIN SUFFICIENT INFORMATION FOR ROOT CAUSE ANALYSIS. NO PRODUCT WAS EXPECTED TO BE RETURNED. REFERENCE RETAIN STRIP TEST RESULT COMPARISON; WHICH MET ACCURACY CRITERIA. AS OF 11/04/2010, 27 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #232170 YIELDING A COMPLAINT RATE OF 0.013%. 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. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 7.5; LAB: 3.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232170

    Patients

    Seq Age Sex Outcome Treatment
    1