BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2201051 · Received July 1, 2011

    Report

    Report Number
    2027969-2011-01453
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS ANEMIC. PER PRODUCT USER GUIDE: LIMITATIONS, HEMATOCRIT RANGES BETWEEN 30 - 55% WILL NOT AFFECT TEST RESULTS. PT CURRENT HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST INR = 3.2, 2ND INR = 2.3, 3RD INR = 2.3, MEAN = 2.60, SD = 0.52, %CV = 19.99. SINCE % CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. RECENT TEST CONDUCTED ON LOT 248203 ON (B)(6) 2011, MET PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 54 = 3.2, 3.2, 3.2 INR; DONOR 55 = 3.9, 4.0, 4.4 INR. IN-HOUSE TEST RESULTS HAVE 0.00% AND 6.45%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. PT REPORTED HAVING ANEMIA, BUT HCT LEVEL IS NOT AVAILABLE. IT MAY HAVE CONTRIBUTED TO UNEXPECTED TEST RESULT. PER PROD USER GUIDE: LIMITATIONS, HEMATOCRIT RANGES BETWEEN 30 - 55% WILL NOT AFFECT TEST RESULTS. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON MET PRECISION CRITERIA. NO PROD WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULTS COMPARISON MET ACCURACY CRITERIA. (B)(4). CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN (B)(4) TESTS. THIS ISSUE WILL BE SUBJECTED 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: DATE: (B)(6) 2011, INRATIO: 3.2, MD'S INRATIO: 2.3, RETEST MD'S INRATIO: 2.3. RESULTS DONE WITHIN MINUTES OF EACH OTHER. 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 248203

    Patients

    Seq Age Sex Outcome Treatment
    1