BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1942329 · Received December 22, 2010

    Report

    Report Number
    2027969-2010-02242
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 22, 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
    AZ, 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: 3.9, 4.6; REFERENCE: 5.1, 5.1; MEAN: 4.50, 4.85; CONFIDENCE LIMITS: 2.5-6.5; 2.6-6.9. INRATIO PRECISION DATA PROVIDED BY END-USER; 1ST INR: 3.9; 2ND INR: 4.6; MEAN: 4.25; SD: 0.49; %CV: 11.65. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT ALL INRATIO VERSUS REFERENCE AND REPEATED INRATIO TEST RESULT COMPARISONS MEET ACCURACY AND PRECISION CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PT WAS TAKING AMOXICILLIN. PER PRODUCT USER GUIDE, CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS, WHICH MAY LEAD TO INACCURATE INR RESULTS. AS REVIEWED ON 12/20/2010, TWENTY-EIGHT DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #225324 YIELDING A COMPLAINT RATE OF 0.051%, 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 DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 3.9, 4.6. LAB: 5.1, 5.1. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 3.9, 4.6. PT'S THERAPEUTIC RANGE: 2.0-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 225324

    Patients

    Seq Age Sex Outcome Treatment
    1 NI