BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123373 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01313
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 10, 2011
    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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 6.4, 2ND INR: 4.7, 3RD INR: 5.2, 4TH INR: 4.9, MEAN: 5.30, SD: 0.76, %CV: 14.37. A 1.9 INR WAS EXCLUDED FROM COMPARISON TEST SINCE RESULT WAS OBTAINED TWO WEEKS PRIOR TO THE OTHER INRATIO TESTS. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID 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 REVIEWED ON (B)(6) 2011, ONE HUNDRED AND SEVEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #248203, YIELDING A COMPLAINT RATE OF 0.069%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD 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: DATE: (B)(6) 2011, INRATIO: 1.9. DATE: (B)(6) 2011, INRATIO: 6.4, 4.7, 5.2, 4.9. PT HAS BEEN SICK WITH ALLERGIES AND HAS BEEN TAKING DECONGESTANTS FOR ABOUT 4 DAYS OR MORE. SHE HAS NOT REPORTED TAKING OVER-THE-COUNTER MEDICATION TO HER DOCTOR. SHE SELF MEDICATED HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1 NI