BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1827588 · Received August 31, 2010

    Report

    Report Number
    2027969-2010-01309
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURACY COMPARISON OF INR VALUES REPORTED BY USER: DATE: (B)(6) 2010, INRATIO: 1.9, REFERENCE: 2.8, MEAN: 2.35, CONFIDENCE LIMITS: 1.4-3.1. INR TEST RESULTS WERE OBTAINED WITHIN 35 MINUTES BETWEEN READINGS. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR'S WERE CALCULATED. ALL 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. THE REPORTED INR VALUES MEET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION 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 OF 08/20/2010, 24 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #218917 YIELDING A COMPLAINT RATE OF 0.030%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARTED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 10, INRATIO: 1.9, LAB: 2.8. METER AND LAB TESTING OCCURRED WITHIN 35 MINUTES OF ONE ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 218917

    Patients

    Seq Age Sex Outcome Treatment
    1