BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1982544 · Received January 11, 2011

    Report

    Report Number
    2027969-2011-00065
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER PERFORMED CORRELATION STUDIES AT FOUR OF THEIR CLINICS. RESULTS AS FOLLOWS: CLINIC 1 (STRIP LOT NUMBER UNK. CLINIC 2 (STRIP LOT #232887). CLINIC 3 (STRIP LOT NUMBER UNK). CLINIC 4 (STRIP LOT #235063). EACH CLINIC USED A DIFFERENT INRATIO METER, DIFFERENT STRIP LOT NUMBER AND DIFFERENT OPERATOR. CUSTOMER DOES NOT HAVE PT INFO FOR ANY OF THE TEST VALUES. POTENTIAL MEDICATIONS OR PT CONDITIONS WERE NOT TAKEN INTO CONSIDERATION DURING THE STUDY. CUSTOMER DID NOT HAVE ANY CRITERIA SET FOR TESTING. IT IS UNK HOW MUCH TIME PASSED BETWEEN TESTING ON THE INRATIO METER AND THE LAB (STAGO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232887

    Patients

    Seq Age Sex Outcome Treatment
    1