BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP MEGA SAMPLE PROCESSOR

    MDR report key: 505634 · Received January 9, 2004

    Report

    Report Number
    1058138-2003-00013
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    December 9, 2003
    Report Date
    December 17, 2003
    Manufacturer
    TECAN AG
    Product Code
    JQW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED INSTRUMENT PIPETTING TIP #4 IS LEAKING/DRIPPING DURING MOVEMENT ACROSS THE WORK SURFACE. A POTENTIAL FOR CONTAMINATION OF BIOHAZARDOUS SPILL IS POSSIBLE, WHICH MAY RESULT IN UNEXPECTED REACTIVITY OF TESTS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INSTRUMENT PIPETTING TIP #4 IS LEAKING/DRIPPING DURING MOVEMENT ACROSS THE WORKTABLE. A POTENTIAL FOR CONTAMINATION OR BIOHAZARDOUS SPILL IS POSSIBLE, WHICH MAY RESULT IN UNEXPECTED REATIVIT OF TEST. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO MICRO TYPING SYSTEMS COMPLAINT 498523.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP MEGA SAMPLE PROCESSOR GENERAL PURPOSE LAB EQUIPMENT JQW TECAN AG 700012 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA