BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2214553 · Received August 3, 2011

    Report

    Report Number
    2027969-2011-01730
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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 METER = 7.5, REFERENCE = 6.2, MEAN = 6.85, CONFIDENCE LIMITS = N/A. DATE: (B)(6) 2011, INRATIO METER = 5.2, REFERENCE = 3.4, MEAN = 4.30, CONFIDENCE LIMITS = 2.4 - 6.1. FOR A, BOTH VALUES ARE ABOVE 5.0 AND GOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. FOR B, 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. RECENT TEST CONDUCTED ON LOT 253026 ON (B)(6) 2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 72 = 4.3, 4.2, 4.4 INR; DONOR 73 = 2.6, 2.1, 2.5 INR. AT LEAST TWO OUT OF THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 72 (3.93 INR) AND DONOR 73 (2.30 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: FOR TEST-A, ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT EST RESULT COMPARISON MET ACCURACY CRITERIA. FOR TEST-B, INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POC AND LABORATORY BASED PT TESTING. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PATIENT'S MEDICATION MAY HAVE CONTRIBUTED TO UNEXPECTED RESULTS. (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

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 7.5, LAB: 6.2; (B)(6) 2011, 5.2, 3.4. THE TIME BETWEEN TESTING WAS TEN MINUTES AND THE PATIENT'S THERAPEUTIC RANGE IS BETWEEN 2.0 AND 3.0. THE CUSTOMER'S LAST DOSE OF COUMADIN WAS (B)(6) AND THE CUSTOMER HELD HER COUMADIN ON (B)(6). THE PATIENT DOES HAVE HYPOTHYROIDISM AND HAD CANCER. THE PATIENT HAS BEEN TAKING A MUSCLE RELAXER SINCE THE BEGINNING OF (B)(6). THE NURSE WAS NOT ABLE TO SPECIFY WHICH ONE.

    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