BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2003817 · Received February 7, 2011

    Report

    Report Number
    2027969-2011-00270
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 THE TIME COMPLAINT WAS FILED. 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 IS REQUIRED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO METER: 7.5 INR, REFERENCE: 5.5 INR, MEAN: 6.5. INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POC AND LABORATORY BASED PT TESTING. NO CONFIDENCE INTERVAL COULD BE ESTABLISHED. NO FURTHER TESTING BEYOND THE INVESTIGATION IS REQUIRED AT THIS TIME. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO METER: 6.5 INR, REFERENCE: 4.1 INR, MEAN: 5.30. THE CALCULATED MEAN IS GREATER THAN 5.0 AND THE DIFFERENCE IS GREATER THAN 2.2 AND ONLY ONE INR VALUE IS GREATER THAN 5.0. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. AS OF (B)(4) 2011, NO STRIP LOT INFO NOR PRODUCT IS EXPECTED TO RETURN. UNABLE TO PERFORM IN-HOUSE INVESTIGATION. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. NO LOT NUMBER INFO WAS PROVIDED BY THE CUSTOMER. 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. METER DISCREPANT HIGH VS LAB ON MULTIPLE PTS. THE CALLER STATED THAT THE HIGH NUMBERS DO NOT CORRELATE WITH PT SYMPTOMS. NO METER SERIAL NUMBER OR STRIP LOT NUMBER PROVIDED. NO INFO ON DATES OF COMPARISONS, PATIENTS' MEDICATIONS OR CLINICAL CONDITIONS.

    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