BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1853388 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01483
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: DATE: (B)(6) 2010; INRATIO: 3.3; REFERENCE: 2.9; MEAN: 3.10; CONFIDENCE LIMITS: 1.8-4.2. DATE: (B)(6) 2010; INRATIO: 3.3; REFERENCE: 2.8; MEAN: 3.05; CONFIDENCE LIMITS: 1.8-4.2. 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. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. 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. STRIP LOT NUMBER WAS NOT PROVIDED BY CUSTOMER. 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 RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: INRATIO: 3.3; LAB: 2.9; COAGUCHECK: 2.8. TESTING WAS FIRST COMPLETED USING COAGUCHECK. ABOUT 2 MINUTES LATER TESTING WAS PERFORMED WITH THE INRATIO METER. ABOUT 10 MINUTES AFTER TESTING WITH INRATIO, THE LAB DRAW WAS TAKEN. PATIENT HAD JUST FINISHED TRAINING REVIEW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1