BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1972717 · Received January 21, 2011

    Report

    Report Number
    2027969-2011-00139
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULT (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FAILED: DATE: NA; INRATIO: 1.5; REFERENCE: 1.9; MEAN: 1.7; CONFIDENCE LIMITS: 1.2 - 2.3. NA; 1.9; 2.2; 2.05; 1.3 - 2.7. 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. NO FURTHER INVESTIGATION IS REQUIRED. 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. AS REVIEWED ON 01/21/2011, 39 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT # 243934 YIELDING A COMPLAINT RATE OF 0.029%. 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. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH. THERE IS NO COMPARABLE DATA INCLUDED IN THE REPORT. MDR WILL NOT BE FILED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULT WITH METER COMPARED TO LAB: DATE: UNK; INRATIO: 1.5; LAB: 1.9. UNK; 1.9; 2.2. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. METER AND LAB DRAWS WERE PERFORMED APPROXIMATELY ONE HOUR APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1