BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 812752 · Received January 29, 2007

    Report

    Report Number
    9681721-2006-00003
    Event Type
    Malfunction
    Date Received
    January 29, 2007
    Date of Event
    November 28, 2006
    Report Date
    January 29, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED TO US, THE CUSTOMER OBESERVED THAT THE BIOHIT PIPETTOR DREW A LESSER AMOUNT OF FLUID THEN WAS INDICATED TO BE DRAWN. ON IMMEDIATE CAUSE WAS DETERMINED AND THE CUSTOMER ABORTED TESTING, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. THE CUSTOMER RESOLVED THIS ISSUE BY THE REPLACING THE PRODUCT WITH A NEW EXACT REPLACEMENT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. BIOHIT HAS NOT RECEIVED TO THE PIPETTE IN QUESTION TO CONFIRM OR REFUTE ANY CLAIMS OF INACCURACY OF THE PIPETTE.

    Description of Event or Problem · 1

    CUSTOMER SAID THAT THIS PIPETTE IS NOT DRAWING UP ENOUGH LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS PIPETTE ELECTRONIC PIPETTOR JTC BIOHIT OYJ 701142MT *

    Patients

    Seq Age Sex Outcome Treatment
    1 *