BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ID TIPMASTER PIPETTOR

    MDR report key: 798507 · Received December 15, 2006

    Report

    Report Number
    1056600-2006-00367
    Event Type
    Malfunction
    Date Received
    December 15, 2006
    Date of Event
    November 17, 2006
    Report Date
    December 15, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    PMA / PMN Number
    BK980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE MTS ID TIPMASTER PIPETTOR WAS DRIPPING DURING ASPIRATION. IT IS UNKNOWN WHICH TEST WERE BEING PERFORMED AT THE TIME OF THE INCIDENT. NO DEFINITIVE ROOT CAUSE WAS DETERMINED CONCERNING THE LEAKAGE OF THE PIPETTOR. THE CUSTOMER DETECTED THE REPORTED ISSUE (FOLLOWING LABELING RECOMMENDATIONS), AND THEN REMOVED THE PIPETTOR FROM USE PREVENTING THE REPORTING OF ERRONEOUS TEST RESULTS. THE CUSTOMER'S ISSUE WAS RESOLVED VIA PRODUCT REPLACEMENT. LABELING CAUTIONS ON THE IMPORTANCE OF DELIVERING THE CORRECT AMOUNT OF CELLS AND PLASMA/SERUM WHEN PERFORMING THE GEL TEST METHOD. THE INSTRUMENT IS A HANDHELD PIPETTOR. THE PIPETTOR IS USED IN PREPARING A MANUAL GEL TEST. A LABORATORY TECHNICIAN CLOSELY MONITORS ALL TESTS. ALL TESTS ARE QUALITATIVE. ALTHOUGH LABORATORY PRACTICES MITIGATE THE POSSIBILITY OF ERRONEOUS PATIENT RESULTS, IF THE ALLEGED MALFUNCTION WERE TO RECUR UNDETECTED, IT COULD LEAD TO ERRONEOUS TEST RESULTS. THEREFORE, INCIDENT IS REPORTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MTS-ID TIPMASTER PIPETTOR WAS LEAKING FLUID DURING ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ID TIPMASTER PIPETTOR MANUAL PIPETTOR GJG MICRO TYPING SYSTEMS, INC. MTS9640 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *