BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2039545 · Received March 22, 2011

    Report

    Report Number
    2027969-2011-00570
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 4.8, 2ND INR: 4.3, 3RD INR: 4.6, MEAN: 4.57, SD: 0.25, %CV: 5.51. A 2.5 INR WAS EXCLUDED FROM COMPARISON TEST SINCE IT WAS PERFORMED (B)(6) PRIOR TO THE OTHER TEST RESULTS. THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4). ACTION THRESHOLD WAS REACHED. SINCE RELEASE OF STRIP LOT, EIGHT IN-HOUSE THERAPEUTIC SAMPLE TESTS AND THREE IN-HOUSE NON-THERAPEUTIC SAMPLE TESTS WERE PERFORMED ON RETAINED AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TESTS. 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. (B)(4). NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. ADD'L LOT #: 241836.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.5. DATE: (B)(6) 2011, INRATIO: 4.8 (STRIP LOT #243934), 4.3 (STRIP LOT #241836), 4.6 (STRIP LOT #241836). PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI