BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1971390 · Received January 11, 2011

    Report

    Report Number
    2027969-2011-00071
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 2.2, 2ND INR: 2.2, MEAN: 2.20, SD: 0.0, %CV: 0.00. THE 2.6 INR WAS EXCLUDED FROM COMPARISON TEST SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS. 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 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. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. AS REVIEWED ON (B)(4) 2011, THIRTY-TWO DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #235737 YIELDING A COMPLAINT RATE OF 0.053%. 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: DATE: (B)(6) 2010, INR: 2.6. DATE: (B)(6) 2010, INR: 2.2. INR: 2.2. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR. PT REPORTED HAVING A BURST BLOOD VESSEL IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other