BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1849782 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01571
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH METERS COMPARED TO LAB. PATIENT #6. DATE: (B)(6) 2010. (B)(6) INRATIO METER: LOT #232171 - 3.1; LOT #236690 - 3.3. (B)(6) INRATIO METER: LOT #232171 - 3.2; LOT #236690 - 3.2. LAB: 2.36. (B)(6) ARE THE INITIALS OF THE NURSE USING TWO DIFFERENT METERS. THESE WERE THE ONLY IDENTIFIERS THE CUSTOMER COULD PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 232171

    Patients

    Seq Age Sex Outcome Treatment
    1