BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1813173 · Received August 18, 2010

    Report

    Report Number
    2027969-2010-01238
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INR RESULTS REPORTED BY THE USER WERE PERFORMED MORE THAN 3 HOURS BETWEEN READINGS. OPTIMALLY, TEST RESULTS SHOULD BE GENERATED WITHIN AS SHORT A TIME AS POSSIBLE TO MINIMIZE THE POSSIBILITY OF FACTORS CONTRIBUTING TO DIFFERENCES IN RESULTS. THE RECOMMENDED REASONABLE TIME DIFFERENCE IS 3 HOURS. DATA ANALYSIS WILL NOT BE PERFORMED. NO FURTHER INVESTIGATION REQUIRED. AS OF 8/13/2010, 12 TOTAL DISCREPANT COMPLAINTS HAVE BEEN REPORTED FOR LOT # 233421 YIELDING A COMPLAINT RATE OF 0.02%. BECAUSE THE RATE IS BELOW THE ACTION THRESHOLD OF 0.07% MONITORED BY QA FOR CORRECTIVE ACTION, 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: NG, INRATIO: 1.1, LAB: 2.6. LAB TESTING WAS PERFORMED THE DAY FOLLOWING INRATIO TESTING. NO ADVERSE MEDICAL CONDITIONS REPORTED. NO MEDICATION CHANGES NOTED. PT HAS BEEN TESTING FOR ONE YEAR AND THIS RESULT IS FROM A NEW BOX OF STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 233421

    Patients

    Seq Age Sex Outcome Treatment
    1