BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2073962 · Received April 20, 2011

    Report

    Report Number
    2027969-2011-00867
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, CUSTOMER WAS HAVING DIFFICULTY OBTAINING SUFFICIENT BLOOD QUICKLY AND SOMETIMES TAKES OVER 30 SECONDS TO OBTAIN BLOOD FOR TESTING. THIS MAY CONTRIBUTE TO UNEXPECTED INR OR ERRORS IN TESTING. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PROLONGING SAMPLE COLLECTION COULD AFFECT TEST RESULTS. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. RETAINED STRIP TEST PERFORMED ON (B)(6) 2011 FOR A PREVIOUS CASE. RESULTS COMPARISON MET ACCURACY CRITERIA. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE VD7HD WHICH BRICK LOT NUMBER 230026 WAS ASSIGNED AND PACKAGED INTO THREE STRIP LOTS (235737 AND 234590). (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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. RESULTS DONE WITHIN 45 MINUTES OF EACH OTHER. TARGET THERAPEUTIC RANGE IS 2.5 - 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1