BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID TIPMASTER

    MDR report key: 785892 · Received November 16, 2006

    Report

    Report Number
    1056600-2006-00281
    Event Type
    Malfunction
    Date Received
    November 16, 2006
    Date of Event
    January 24, 2005
    Report Date
    November 16, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPETTE WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS VERIFIED. THE CUSTOMER WAS SENT A REPLACEMENT PIPETTE. PRODUCT LABELING INSTRUCTS THE USER TO PERFORM QC OR VERIFICATION DAILY, MINIMIZING THE POSSIBILITY OF ERRONEOUS RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED THAT THE TIPMASTER PIPETTOR IS NOT ASPIRATING PROPERLY. IMPROPER ASPIRATION VOLUME COULD LEAD TO ERRONEOUS TEST RESULTS. THERE WAS NO REPORT OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ID TIPMASTER INSTRUMENT GJG MICRO TYPING SYSTEMS, INC. MTS9640 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *