BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123348 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01308
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY CUSTOMER. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2011. 1ST INR = 3.2; 2ND INR = 2.3. MEAN = 2.75; SD = 0.64; %CV = 23.14. SINCE % CV IS MORE THAN 20%, THE TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT 247451 ON 5/16/2011 MET PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 32 = 2.8, 3.0, 2.8 INR: DONOR 3 = 3.0, 3.1, 3.1 INR. IN-HOUSE TEST RESULTS HAVE 4.03% AND 1.88%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935 WHICH BRICK LOT NUMBER 237418 WAS ASSIGNED AND PACKAGED INTO TWO STRIP LOTS (247450 AND 247451). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4). CORRECTIVE ACTION IS NOT 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:" 3.2 AND 2.3. CALLER REPORTS TESTING TWICE WITHIN SEVERAL MINUTES ON SAME FINGER AND SAME FINGER STICK AND RESULTING INR OF 3.2 AND THEN 2.3. PATIENT THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1