BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1812224 · Received August 20, 2010

    Report

    Report Number
    2027969-2010-01252
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ALERE SAN DIEGO, INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(4). 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 1.4. DATE: (B)(6) 2010, INRATIO: 4.3. DATE: (B)(6) 2010, INRATIO: 2.6. BASED ON THE (B)(6) 2010 INRATIO READING OF 4.3 INR, THE DOCTOR HELD A DOSE AND HALVED THE NEXT TWO DOSES OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INCORPORATED 100071 225433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other