BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2166589 · Received July 5, 2011

    Report

    Report Number
    2027969-2011-01463
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 5, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 6.4; 2ND INR: 1.9; MEAN: 4.15; SD: 3.18; %CV: 76.67. THE 6.2 INR RESULT WAS EXCLUDED FROM COMPARISON TEST SINCE NO CORRESPONDING REFERENCE OR REPEATED INRATIO VALUE WAS PROVIDED. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON (B)(6) 2011, REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT #248203: DONOR 54: 1ST INR: 3.2; 2ND INR: 3.2; 3RD INR: 3.2; MEAN: 3.20; SD: 0.00; %CV: 0.00. DONOR 55: 4.2; 4.2; 4.0; 4.13; 0.12; 2.79. %CV FOR BOTH DONORS ARE LESS THAN 16%. NO FURTHER INVESTIGATION WILL BE PURSUED. (B)(4). ACTION THRESHOLD (B)(4) WAS REACHED. FROM 08/19/2010 TO 07/05/2011, EIGHTEEN THERAPEUTIC AND THREE NORMAL DONOR TESTS HAVE BEEN PERFORMED. TEST RECORDS INDICATED 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.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: NG; INRATIO: 6.4; 1.9; (B)(6) 2011; 6.2. PT'S THERAPEUTIC RANGE: 2-3 INR.

    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 NI