BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3145275 · Received May 30, 2013

    Report

    Report Number
    2027969-2013-00435
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 19, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2013, 1ST INR = 2.9, 2ND INR = 1.6, 3RD INR = 2.1, MEAN = 2.2, SD = 0.66, %CV = 29.81. SINCE %CV EXCEEDS 20%, INRATIO METER RESULTS DO NOT PASS THE CRITERIA FOR PRECISION. FURTHER TESTING IS REQUIRED. THE LAST IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON REPORTED LOT 305773 ON (B)(6) 2013 YIELDED THE FOLLOWING RESULTS: DONOR (B)(6), INRATIO: 2.3, 2.0, 2.0, REF: 2.51, BIAS THRESH: 1.51 - 3.51, %CV: 8.25; DONOR (B)(6), 2.6, 2.7, 2.9; 3.31; 2.31 - 4.31; 5.59. ALL REPLICATES FOR EACH DONOR WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAD BEEN MET. NO FURTHER INVESTIGATION 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 FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. AS REVIEWED ON 5/28/2013, 46 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #305773 YIELDING A COMPLAINT RATE OF (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. NO CORRECTIVE ACTION AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT IMPRECISION. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 2.9, REPEAT 1: 1.6, REPEAT 2: 2.1. ALL THREE TESTS PERFORMED WITHIN MINIMIZE OF EACH OTHER USING DIFFERENT FINGERS. PT'S THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237681 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 305773

    Patients

    Seq Age Sex Outcome Treatment
    1