BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1853447 · Received September 28, 2010

    Report

    Report Number
    2027969-2010-01589
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 28, 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
    FL, 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: 6.2, REFERENCE: 3.8, MEAN: 5.00, CONFIDENCE LIMITS: 2.8-7.2. ANALYSIS OF THE CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON MEET ACCURACY CRITERIA. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PER GENERAL DESCRIPTION OF COMPLAINT, CUSTOMER HAS ATRIAL FIBRILLATION AND WAS OVERDOSED WITH COUMADIN. PATIENT'S CURRENT HEALTH CONDITION AND MEDICATION MAY HAVE AFFECTED COAGULATION TESTING AND MAY HAVE LED TO THE UNEXPECTED INR RESULTS. NO PRODUCT IS EXPECTED TO BE RETURNED. NO PRODUCT INFORMATION WAS PROVIDED BY THE CUSTOMER. COMPLAINT 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) 2010, INRATIO: 6.2, LAB: 3.8. THERAPEUTIC RANGE: 2.0-3.0 INR PATIENT WAS OUT OF RANGE AT THE LAB BECAUSE, HE WAS NOT USING A PILL BOX AND ACCIDENTALLY OVERDOSE ON COUMADIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI