BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2231017 · Received July 19, 2011

    Report

    Report Number
    2027969-2011-01586
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 19, 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

    CUSTOMER HAS HYPOTHYROIDISM AND RENAL DISEASE. CUSTOMER UNDERGOES DIALYSIS AND TAKES AMIODARONE. PT CURRENT MEDICATION AND HEALTH STATUS MAY AFFECT COAGULATION TEST. THIS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 4.7, REF: 2.8, MEAN: 3.75, CONFIDENCE LIMITS: 2.2 - 5.3. 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 OF 3.6 FROM (B)(6) 2011 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. RECENT TEST CONDUCTED ON LOT# 251117 ON 07/11/2011 MET ACCURACY 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 OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR -1.0) OF REFERENCE RESULTS FOR DONOR 68 (2.86 INR) AND DONOR 70 (3.86 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED. RECENT RETAIN STRIP RESULTS MET ACCURACY CRITERIA. PT'S CONDITIONS, MEDICAL TREATMENTS AND MEDICATIONS AS A CAUSE OF THE UNEXPECTED RESULTS CANNOT BE RULED OUT. (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. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.7, LAB: 2.8 (TESTING WITHIN 10-15 MINUTES APART). DATE: (B)(6) 2011, INRATIO: 3.6. PT HAS BEEN TAKING COUMADIN FOR AT LEAST A COUPLE OF MONTHS. LAST DOSE OF COUMADIN TAKEN THURSDAY (B)(6) 2011, 6PM 2.5MG.

    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