BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 934609 · Received April 10, 2007

    Report

    Report Number
    9681721-2007-00006
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    February 13, 2007
    Report Date
    April 9, 2007
    Manufacturer
    BIOHIT OYJ
    Product Code
    JTC
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BIOHIT PIPETTOR WAS NOT DISPENSING PROPERLY. THE CUSTOMER IMMEDIATELY DISCONTINUED USE OF THE DEVICE. INFORMATION WAS NOT PROVIDED REGARDING TESTING PERFORMED WITH THE PIPETTOR OR POSSIBLE TEST RESULTS OBTAINED OR HOW THE CUSTOMER DISCOVERED THE ISSUE. ERRONEOUS RESULTS WERE NOT REPORTED. THE CUSTOMER WAS PROVIDED A REPLACEMENT PIPETTOR AND INSTRUCTED TO FORWARD THE AFFECTED PIPETTOR TO AN OCD REPAIR DEPOT (JABIL). ON 3/9/2007 THE PIPETTOR WAS EVALUATED BY AN OCD REPAIR DEPOT (JABIL). THE REPAIR DEPOT INDICATED THAT THE PIPETTOR DID NOT DISPENSE THE CORRECT VOLUME OF FLUID. THE CUSTOMER COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    INCORRECT OR NO DISPENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS PIPETTE ELECTRONIC PIPETTOR JTC BIOHIT OYJ 710142MT *

    Patients

    Seq Age Sex Outcome Treatment
    1 *