BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123394 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01312
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    P21923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 5.3, REFERENCE: 3.5, MEAN: 4.40, CONFIDENCE LIMITS: 2.5-6.5. INR RESULTS FROM (B)(6) 2011 WERE EXCLUDED FROM COMPARISON TEST SINCE THEY WERE ALL OBTAINED ON DIFFERENT DAYS WITH NO CORRESPONDING LAB VALUE. 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 INRATIO AND REFERENCE TEST RESULT COMPARISON DID MEET ACCURACY 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. (B)(4). ACTION THRESHOLD (B)(4) WAS REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935, WHICH BRICK LOT #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), NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 5.3, LAB: NG; (B)(6) 2011, 5.3, NG; (B)(6) 2011, 2.1, NG; (B)(6) 2011, 5.3, 3.5.

    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 NI