BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1972718 · Received January 21, 2011

    Report

    Report Number
    2027969-2011-00160
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 21, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.7; REFERENCE: 3.9; MEAN: 3.30; CONFIDENCE LIMITS: 1.9-4.6. INRATIO: 3.8; 3.9; 3.85; 2.2-5.3. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 2.7; 2ND INR: 3.8; MEAN: 3.25; SD: 0.78; %CV: 23.93. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS DID MEET ACCURACY CRITERIA. HOWEVER, REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT PRECISION CRITERIA WAS MET. AS REVIEWED ON 01/21/2011, ONE HUNDRED AND FIVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 233708, YIELDING A COMPLAINT RATE OF 0.078%. ACTION THRESHOLD WAS REACHED. SINCE RELEASE OF STRIP LOT, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAINED AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN TEST. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT # 233708. SINCE % CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 2.7; LAB: 3.9. INRATIO: 3.8; 3.9. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR: 2.7; 3.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1 NI