BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2230948 · Received July 20, 2011

    Report

    Report Number
    2027969-2011-01590
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, PT HAS HYPOTHYROIDISM. PT'S CURRENT HEALTH MAY AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR OR ERRORS IN TESTING. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.2, REFERENCE: 1.7, MEAN: 1.45, CONFIDENCE LIMITS: 1.1 - 1.9. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO FURTHER INVESTIGATION IS REQUIRED. INR RESULT OF 1.4 WAS EXCLUDED FROM DATA ANALYSIS BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST INR: 1.8, 2ND INR: 1.4, MEAN: 1.60, SD: 0.28, %CV: 17.68. SINCE % CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. RECENT TEST CONDUCTED ON LOT 251117 ON 07/11/2011 MET BOTH ACCURACY AND PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 68 = 2.7, 3.0, 3.0 INR; DONOR 70 = 3.9, 3.8, 3.9 INR. AT LEAST TWO OUT THREE REPLICATE ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 68 (2.86 INR) AND DONOR 70 (3.86 INR), RESPECTIVELY. IN-HOUSE TEST RESULTS HAVE 5.97% AND 1.49%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. PT'S CONDITION MAY HAVE CONTRIBUTED TO UNEXPECTED RESULTS. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULTS COMPARISON MET ACCURACY CRITERIA. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULTS COMPARISON MET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY AND PRECISION 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: UNK, INRATIO: 1.4; (B)(6) 2011, 1.2, LAB: 1.7. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. LAB RESULT DONE WITHIN AN HOUR OF METER RESULT. CALLER TESTED HERSELF (SHE IS ALSO ON COUMADIN WITH A THERAPEUTIC RANGE 2.0-3.0). SHE TESTED AROUND THE SAME TIME WITH A DIFFERENT (UNK) LOT. CALLER TESTED AROUND THE SAME TIME AS PT. DATE: UNK, INRATIO1: 1.8, INRATIO2: 1.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251117

    Patients

    Seq Age Sex Outcome Treatment
    1