BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2000490 · Received January 31, 2011

    Report

    Report Number
    2027969-2011-00219
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES GETTING ERROR MESSAGES WITH METER. CUSTOMER ATTEMPTED TO CHANGE THE BATTERIES, BUT FOUND THAT THEY HAD MELDED TOGETHER. CUSTOMER ALLEGED THAT THE NURSE "ALMOST BURNED HER FINGERS", BUT CLARIFIED THAT THE NURSE WAS NOT INJURED OR HARMED.

    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