BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1954221 · Received December 9, 2010

    Report

    Report Number
    2027969-2010-02142
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: INRATIO: 1.2, REFERENCE: 2.3, MEAN: 1.75, CONFIDENCE LIMITS: 1.2 - 2.3. INRATIO: 1.5, REFERENCE: 2.2, MEAN: 1.85, CONFIDENCE LIMITS: 1.2 - 2.3. INR RESULTS FROM (B)(6) 2010 THROUGH (B)(6) 2010, WERE EXCLUDED FROM COMPARISON TEST SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS. THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OR THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PATIENT WAS ON LOVENOX. PER LIMITATIONS OF PRODUCT, INRATIO TESTING SHOULD NOT BE USED FOR PATIENTS ON LOVENOX SINCE THE MEDICATION MAY AFFECT COAGULATION TESTING. AS REVIEWED ON 12/09/2010, FOURTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #229442 YIELDING A COMPLAINT RATE OF 0.008%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS. CALLER ALSO ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB: RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.2, LAB: 2.3. (B)(6) 2010, 1.5, 2.2. CUSTOMER THINKS NURSE MADE CLERICAL ERROR ON (B)(6) 2010, FOR INRATIO = 1.2 INR. PATIENT JUST STARTED COUMADIN THERAPY ON (B)(6) 2010 AND WAS GIVEN LOVENOX ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 229442

    Patients

    Seq Age Sex Outcome Treatment
    1 NI