BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1894145 · Received November 4, 2010

    Report

    Report Number
    2027969-2010-01880
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 4, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 4.0; 2ND INR: 3.4; MEAN: 3.70; SD: 0.42; %CV: 11.47. THE 1.8 AND 2.8 INR RESULTS WERE EXCLUDED FROM COMPARISON TEST SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR THE COMPARISON TO BE VALID. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON MEET 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. AS OF 11/04/2010, THIRTY-EIGHT DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.028%. 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 IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1 NI