BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1864546 · Received October 4, 2010

    Report

    Report Number
    2027969-2010-01647
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 2.6, 2ND INR: 2.5, MEAN: 2.55, SD: 0.07, %CV: 2.77. THE 1.6 INR WAS EXCLUDED FROM COMPARISON TEST SINCE THE TIME OF TEST WAS MORE THAN THREE HOURS FROM THE OTHER TESTS. THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. 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 DOCUMENTED VARIABILITY FOR INR TESTING. NO FURTHER INVESTIGATION REQUIRED AT THIS TIME. NO PRODUCT IS EXPECTED TO BE RETURNED. NO PRODUCT INFORMATION WAS PROVIDED BY THE CUSTOMER. COMPLAINT 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. RESULT AS FOLLOWS: DATE: (B)(6) 2010. INR: 1.6 (9:00 AM), 2.6 (1:00 PM), 2.5 (3:00 PM).

    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 NI