BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2669781 · Received July 20, 2012

    Report

    Report Number
    2027969-2012-01112
    Event Type
    Injury
    Date Received
    July 20, 2012
    Date of Event
    June 24, 2012
    Report Date
    July 20, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 3.5, 2ND INR: 3.0, MEAN: 3.25, SD: 0.35, %CV: 10.88. 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. PER COMPLAINT ISSUE, PT USED EXPIRED STRIPS, WHICH MAY HAVE CONTRIBUTED TO INACCURATE INR RESULTS. NO FURTHER INVESTIGATION IS REQUIRED. AS REVIEWED ON (B)(4) 2012, 64 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243394, YIELDING A COMPLAINT RATE OF 0.1067%. ACTION THRESHOLD (>0.07%) WAS REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE (B)(4) WITH BRICK LOT #246550, WHICH WAS ASSIGNED AND PACKAGED INTO 3 STRIP LOTS (243394, 253028 AND 253024). THEREFORE, 137 TOTAL DISCREPANT COMPLAINTS HAVE BEEN REPORTED FOR THESE 3 LOTS, YIELDING A TOTAL COMPLAINT RATE OF 0.041%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF 0.10%, NO ACTION IS REQUIRED AT THIS TIME. AS REVIEWED ON (B)(4) 2012, 8 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #281261, YIELDING A COMPLAINT RATE OF 0.021%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF >0.07%, NO ACTION IS REQUIRED AT THIS TIME. COMPLAINT ISSUE WILL BE SUBJECT TO TRACKING AN 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) 2012, INRATIO: 3.5 (STRIP LOT #273394), 3.0 (STRIP LOT #281261). TIME BETWEEN TESTING: 45 MINUTES. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. PT HAS BEEN TESTING ON THE INRATIO METER FOR ABOUT 5 YEARS. SHE STATES THAT THE DOCTOR HAS TRUSTED HER TO DOSE HERSELF. PT IS USUALLY VERY STABLE AND WITHIN HER RANGE. HOWEVER, SHE NOTICED THAT HER RESULTS HAVE BEEN TRENDING HIGHER SINCE (B)(6) 2012. PT HAS DECREASED HER WARFARIN DOSE. HOWEVER, SHE IS STILL OBTAINING HIGHER RESULTS. SHE NOTICED THAT SHE WAS BRUISING EASILY WHILE SHE WAS GARDENING. PT TESTED WITH EXPIRED (#273394) AND NON-EXPIRED (#281261) STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243394

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other