BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3150125 · Received June 3, 2013

    Report

    Report Number
    2027969-2013-00443
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPROPER TECHNIQUES WERE IDENTIFIED BY (B)(4). IMPROPER TECHNIQUES MAY LEAD TO INACCURATE RESULTS. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2013, 1ST INR = 5.1, 2ND INR = 2.1, MEAN = 3.6, SD = 2.12, %CV = 58.93. INRATIO METER RESULTS FAILED THE CRITERIA FOR PRECISION WITH %CV GREATER THAN (B)(4). IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON REPORTED LOT # 305771 ON (B)(4) 2013. RESULTS AS FOLLOWS: (B)(4). NO FURTHER INVESTIGATION WAS REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED OF INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. (B)(4). NO CORRECTIVE ACTION AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT IMPRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, IRATIO: 5.1, REPEAT: 2.1. TIME BETWEEN TESTING WAS REPORTED AS 3 MINUTES. PT'S THERAPEUTIC RANGE IS 2.0 - 3.0. IT WAS REPORTED THE PT SELF TESTER (PST) WAS MILKING THEIR FINGER AND TOUCHING THEIR FINGER TO THE STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242895 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 305771

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN