BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1789412 · Received July 28, 2010

    Report

    Report Number
    2027969-2010-01075
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INR RESULTS PROVIDED BY THE CUSTOMER WERE PERFORMED MORE THAN THREE HOURS APART. 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 THE COMPARISON TO BE VALID. DATA ANALYSIS WILL NOT BE PERFORMED AND NO FURTHER INVESTIGATION WILL BE PURSUED. CUSTOMER ALSO REPORTED "LO" ERRORS. PER PROFESSIONAL USER GUIDE, THE AMBIENT TEMPERATURE IS TOO COLD FOR THE MONITOR TO OPERATE PROPERLY. TO TROUBLESHOOT THIS ERROR, IT IS ADVISED THAT THE USER MOVE THE MONITOR TO A WARMER LOCATION AND TRY AGAIN IN A FEW MINUTES. AS OF 07/28/2010, ONE DISCREPANT RESULT COMPLAINT WAS REPORTED FOR LOT #232886 YIELDING A COMPLAINT RATE OF 0.001%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. 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) 2010, INRATIO: 1.6, LAB: NG. DATE: (B)(6) 2010, INRATIO: 2.7, LAB: NG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 232886

    Patients

    Seq Age Sex Outcome Treatment
    1 NI