BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2000641 · Received February 2, 2011

    Report

    Report Number
    2027969-2011-00241
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 2, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA ANALYSIS WAS PERFORMED ON CUSTOMER'S RESULTS SINCE PT USED STRIPS THAT EXPIRED ON 11/30/2010. RETAINED STRIP TEST RECORDS WERE REVIEWED AND REVEALED THAT ALL STRIP TESTS THAT WERE PERFORMED DID NOT REPLICATE CUSTOMER'S OBSERVATION. SINCE STRIPS IN COMPLAINT WERE EXPIRED, NO TRENDING IS REQUIRED. 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: (B)(6) 2011, INRATIO: 4.8, 2.8, 3.8, 3.4. PT USED EXPIRED STRIPS ((B)(6) 2010). PT'S THERAPEUTIC RANGE: 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 222168

    Patients

    Seq Age Sex Outcome Treatment
    1 NI