BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1970459 · Received January 18, 2011

    Report

    Report Number
    2027969-2011-00123
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTS POWER SUPPLY CORD AT THE INDICATOR LIGHT IS SLIGHTLY MELTED AND NO LONGER POWERS ON METER. BATTERIES THAT MAY NOT BE NEW ALSO FAILED TO POWER ON METER. SITE HAS BACK UP GENERATOR THAT HAS BEEN RUNNING A LOT LATELY AND MAY BE CAUSING SURGES IN POWER. REPLACEMENTS POWER CORD SENT, BUT THIS DID NOT RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200457 NG

    Patients

    Seq Age Sex Outcome Treatment
    1