BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2903390 · Received December 14, 2012

    Report

    Report Number
    2027969-2012-01692
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIME ELAPSED BETWEEN THE INRATIO TEST AND LAB REFERENCE TEST IS NOT PROVIDED BY CUSTOMER. IF THE TIME ELAPSED EXCEEDS 3 HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: (B)(4). THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE INRATIO VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. CASE DID NOT INCLUDE INFO REGARDING FINGER STICK TECHNIQUE, PT CONDITION OR PRODUCT STORAGE CONDITIONS. ROOT CAUSE CAN NOT BE DETERMINED WITHOUT MORE INFO. UNABLE TO PERFORM RETAINED STRIP TEST DUE TO UNK STRIP LOT NUMBER ON THE EVENT DETAILS. NO FURTHER INVESTIGATION IS POSSIBLE. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADD'L INFO. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: INRATIO 0.9, LAB 1.9. CALLER DID NOT PERFORM THE TEST AND DOES NOT HAVE ACCESS TO PT RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139

    Patients

    Seq Age Sex Outcome Treatment
    1