BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS PIPETTE

    MDR report key: 899049 · Received August 20, 2007

    Report

    Report Number
    9681721-2007-00015
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    June 25, 2007
    Report Date
    August 18, 2007
    Manufacturer
    BIOHIT OVJ LAIPPATIE 1 HELSINKI
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN UNEVEN AMOUNT OF FLUID WAS DRAWN AND THE PIPETTE WAS REMOVED FROM SERVICE. THE PIPETTE DEEMED TO HAVE AN ADDITIONAL STRUCTURAL FAILURE WAS NOT ABLE TO BE EVALUATED TO CONFIRM UNEVEN DRAW. THE PIPETTE RESIDES AT THE TESTING FACILITY AND HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO EVENTS ENDANGERED ANY PATIENT OR ALTERED ANY TEST RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THEY WERE ATTEMPTING TO PERFORM PATIENT TESTING WITH THE BIOHIT PIPETTOR AND NOTICED THAT THE PIPETTOR HAD DISPENSED AN INCORRECT AMOUNT OF FLUID. THE CUSTOMER ABORTED TESTING AND DISCONTINUED THE USE OF THE PIPETTOR. THE CUSTOMER INDICATED THAT THE PIPETTOR WAS DISPENSING LESS FLUID ON ANY PROGRAMMING MODE. QC TESTING ALSO FAILED. NO ERRONEOUS RESULTS WERE REPORTED. ISSUE RESOLVED THROUGH PRODUCT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS PIPETTE ELECTRONIC PIPETTOR JTC BIOHIT OVJ LAIPPATIE 1 HELSINKI 710142MT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR