BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1924797 · Received December 10, 2010

    Report

    Report Number
    2027969-2010-02152
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED DUE TO IMPROPER TECHNIQUE. CUSTOMER WAS MILKING THE FINGER. PER PRECAUTIONS AND WARNINGS OF THE PRODUCT USER GUIDE, IT IS ADVISED THAT USERS DO NOT USE REPETITIVE PRESSURE TO COLLECT THE BLOOD SAMPLE. MILKING THE FINGER RELEASES INTERSTITIAL FLUIDS THAT MAY CAUSE INACCURATE RESULTS. PER GENERAL DESCRIPTIONS OF COMPLAINT, PT JUST STARTED PREGNAZONE. PER PRODUCT USER GUIDE, CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS CAN AFFECT THE ACTION OF THE ORAL ANTI-COAGULATIONS. STARTING OR CHANGING DOSES CAN AFFECT THE INR VALUE. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT TEST RESULT COMPARISONS MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION REQUIRED. AS REVIEWED ON 12/07/2010, TWENTY-SEVEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 225937 YIELDING A COMPLAINT RATE OF 0.008%. 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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT# 225937. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND SYSMEX INRS WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 225937 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 7.4, LAB: 5.0. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 225937

    Patients

    Seq Age Sex Outcome Treatment
    1 NI