BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2004524 · Received February 23, 2011

    Report

    Report Number
    2027969-2011-00384
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011; 1ST INR = 4.0; 2ND INR = 3.3; MEAN = 3.65; SD = 0.49; %CV = 13.56. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT THE TEST RESULT COMPARISON MET PRECISION CRITERIA. CUSTOMER MADE NO REFERENCE OF SAMPLE COLLECTION/DROPPING TECHNIQUE. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. AS REVIEWED ON 2/12/2011, 41 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #233421 YIELDING A COMPLAINT RATE OF 0.068%. 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 REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011; INRATIO: 4.0; LAB: 3.3. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 233421

    Patients

    Seq Age Sex Outcome Treatment
    1