BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000483 · Received February 1, 2011

    Report

    Report Number
    2027969-2011-00227
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    LZG
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 2011, INRATIO: 6.3, REFERENCE: 8.5, MEAN: 7.4, CONFIDENCE LIMITS: NA. THE MEAN IS >5.0 AND THE DIFFERENCE IS 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADD'L INVESTIGATION IS REQUIRED. INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POINT OF CARE AND LAB BASED PT TESTING. PREVIOUS INVESTIGATION OF STRIP LOT 237433 FROM A PREVIOUS CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. STRIP INVESTIGATION WAS PERFORMED ON LOT 243934. GREATER THAN +/- 1.0 BIAS IS OBTAINED ON RETURNED UNIT. TWO MORE DONORS WILL BE TESTED TO ELIMINATE THE POSSIBILITY THAT THE FAILURE IS DUE TO DONOR SPECIFIC EFFECT. ADD'L INVESTIGATIONS ARE PERFORMED ON (B)(4) 2011: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 243934 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. COMPARISON INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POINT OF CARE AND LAB BASED PT TESTING. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (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

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 6.3, LAB: 8.5. RESULTS DONE WITHIN MINUTES OF EACH OTHER. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST LZG ALERE SAN DIEGO, INC. 100139 237433

    Patients

    Seq Age Sex Outcome Treatment
    1