BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2273796 · Received August 30, 2011

    Report

    Report Number
    2027969-2011-01898
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 30, 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

    PER ISSUE, STRIP CODE WAS ENTERED INCORRECTLY. USING INCORRECT STRIP CODE ON UNIT MAY CONTRIBUTE TO UNEXPECTED OR INACCURATE INR RESULT. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 5.1 INR, REFERENCE: 10.0 INR, MEAN: 7.55, CONFIDENCE LIMITS: NA (FAIL). DATE: (B)(6) 2011, INRATIO: 6.1 INR, REFERENCE: 4.5 INR, MEAN: 3.05, CONFIDENCE LIMITS: 1.4-5.2. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT. INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. RECENT TEST CONDUCTED ON LOT 253026 ON (B)(6) 2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 88 = 4.1, 4.0, 4.5 INR; DONOR 89 = 3.0, 3.8 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 88 (3.43 INR) AND DONOR 89 (3.02 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. INRATIO PACKAGE INSERT ADVISES CUSTOMER TO USE FIRST DROP OF SAMPLE FOR TEST ACCURACY. CUSTOMER REPORTED INRATIO INR = 5.1, LAB INR 10. INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POC (POINT OF CARE) AND LABORATORY BASED PT TESTING. FOR INRATIO INR = 1.6, LAB INR = 4.5, ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. AS REVIEWED ON (B)(6) 2011, 25 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT 253026 YIELDING A COMPLAINT RATE OF 0.006% DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.075) 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: PATIENT 1, DATE: (B)(6) 2011, INRATIO: 5.1, LAB: 10.0. PATIENT 2, DATE: (B)(6) 2011, INRATIO: 1.6, LAB: 4.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1