BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2102605 · Received May 20, 2011

    Report

    Report Number
    2027969-2011-01124
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PROVIDED STRIP CODE (DZ0L9) BUT NO LOT NUMBER FOR SECOND LOT OF STRIPS TESTED. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 2.0, 1.9 AND 1.2. NURSE CALLED IN TO MAKE SURE THAT THE INRATIO AND INRATIO2 STRIPS ARE COMPARABLE IN HER INRATIO METER. TESTED SAME PT 3 TIMES; 2 TIMES USING INRATIO STRIPS, 1 TIME USING INRATIO2 STRIPS. ONLY ABLE TO PROVIDE LOT NUMBER FOR INRATIO STRIPS AND STRIP CODE FOR INRATIO2 STRIPS: INRATIO=2.0, 1.9, INRATIO2=1.2. NURSE TESTED HERSELF WITH INRATIO2 STRIPS; INR=1.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 247456

    Patients

    Seq Age Sex Outcome Treatment
    1