BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2287823 · Received October 4, 2011

    Report

    Report Number
    2027969-2011-02053
    Event Type
    Injury
    Date Received
    October 4, 2011
    Date of Event
    September 5, 2011
    Report Date
    October 4, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAS A BRUISED FINGER. CUSTOMER WAS MILKING AND SMEARING BLOOD ON THE STRIP SAMPLE WELL. PT CURRENT HEALTH STATUS AND TECHNIQUES MAY CONTRIBUTE TO UNEXPECTED INR RESULT. NES ERRORS OCCUR WHEN THERE IS NOT ENOUGH SAMPLE APPLIED TO THE TEST STRIP TO FILL THE TEST AREA, AND/OR STRIP CHANNEL IS BLOCKED. THERE IS NO CLINICAL SIGNIFICANCE IN THE DISCREPANCY ANALYSIS FOR CUSTOMER DID NOT PROVIDE THE INRATIO AND LAB VALUE TO CALCULATE THE CONFIDENCE LIMIT. RECENT TEST CONDUCTED ON LOT #262184 ON (B)(6) 2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 110 = 1.9, 2.1, 2.0 INR: DONOR 111 = 1.7, 1.8, 1.7 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF REFERENCE RESULTS FOR DONOR 110 (1.94 INR) AND DONOR 111 (1.78 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CUSTOMER REPORTED DIFFICULTY OBTAINING SAMPLE AND OBTAINING NES ERRORS. SAMPLE MAY HAVE SMEARED ON THE STRIPS. THIS PRE-ANALYTICAL TECHNIQUE MAY CONTRIBUTE TO INACCURATE INR RESULT OR TESTING ERROR. CUSTOMER WAS MILKING THE FINGER. PER PRODUCT USER GUIDE - PRECAUTIONS AND WARNINGS, "DO NOT USE REPETITIVE PRESSURE TO COLLECT THE SAMPLE. "SQUEEZING THE FINGER STICK SITE EXCESSIVELY (MILKING) RELEASES INTERSTITIAL FLUID AND MAY CAUSE INACCURATE RESULTS. RETAIN STRIP TESTING DID NOT REPRODUCE THE ISSUE. (B)(4). THE ACTION THRESHOLD (B)(4) HAS BEEN REACHED. AS A RESULT, A REVIEW OF RETAIN TESTING HISTORY SHOWED THAT THE LOT HAS BEEN TESTED WITH 46 RETAIN AND RETURNED STRIPS. THE ISSUE HAS NOT BEEN REPLICATED IN-HOUSE. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: PT SELF TESTER REPORTED GETTING LO (NES) ERRORS FIVE TIMES. PT NOTED THAT THE BLOOD DROP RUNS OFF HIS FINGER; HE TRIES TO USE A SMALLER DROP BUT IT DOES NOT TEST PROPERLY. BLOOD SMEARS A LITTLE ON THE STRIP AND HE ALSO HAS A HARD TIME GETTING A SUFFICIENT SAMPLE. PATIENT PRICKS THE SIDE OF THE FINGER. PT NOTED THAT HIS FINGER WAS BRUISED FROM MILKING TO GET BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 262184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other