BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2022518 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00324
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED BECAUSE OF IMPROPER TECHNIQUE. PER TECHNICAL SERVICES REP, PT WAS TESTING THE SAME FINGER. RE-STICKING THE SAME SITE MAY HAVE CAUSED PRE-ANALYTICAL ERRORS IN FINGERSTICK. ALSO, INR RESULT FROM (B)(6) 2011 COULD NOT BE INCLUDED IN DATA ANALYSIS BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PREVIOUS INVESTIGATION OF STRIP LOT 243934 FROM A PREVIOUS CASE MET PRECISION CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. INR REPORTED ARE REGISTERED ON MEMORY STRIP INVESTIGATION WAS PERFORMED ON LOT 243934. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 243934, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 6.67% AND 2.84%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 2.2; DATE: (B)(6) 2011, INRATIO: 5.5, RETEST INRATIO: 4.2. PT'S TARGET THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1